Games vs. Mobile Health Monitoring Devices: Which is a Better Motivator?

What could possibly justify spending $8,000 for an electronic mobile ultrasound device vs. $100 for a stethoscope? Keep in mind that the stethoscope will likely last a lifetime, whereas the electronic device -- like my son's iPod -- may last only a couple of years before failing or becoming obsolete even sooner.

"Why would I listen to 'lub dub' when I can see everything?" said a doctor quoted in today's Wall Street Journal (see "Can Mobile Monitoring Devices Improve Medical Treatment?"). "Dr. Topol, a cardiologist in San Diego, carries with him instead a portable ultrasound device roughly the size of a cellphone [see image]. When he puts it to a patient's chest, the device allows him to peer directly into the heart. The patient looks, too; together, they check out the muscle, the valves, the rhythm, the blood flow."

Doctors, especially cardiologists, are notorious gadget geeks, so you have to take their enthusiasm for electronic devices with a grain of salt, especially when they claim that the devices will improve health care.

"[Dr. Topol] and other physicians say the technology can not only improve diagnoses and treatment, but also revolutionize how doctors and patients think about health care. Mobile tools allow physicians to monitor vital signs, note changes in activity levels and verify that medications have been taken, without ever seeing a patient face to face."

I wasn't aware that physicians were even interested in "verifying that medications have been taken" let alone that they would buy expensive devices to help them do that. Most physicians don't want to take on that responsibility and be legally liable. Also, who will pay for the service, especially when the physician makes a substantial investment in devices? The same goes for "monitoring vital signs" and other forms of monitoring patients from afar. "We're getting virtual touch, rather than actual touch," says Dr. Topol.

Dr. Topol "found that many [of his] patients are more willing to make lifestyle changes that keep them healthy when they can monitor the consequences of their actions in real time. A doctor can talk 'until he's blue in the face,' he says, but it sometimes takes cold, hard data to motivate a patient."

Social gaming enthusiasts disagree. "We tried to give people constant feedback about [patients'] health, but for a lot of people, more bad news and negative feedback just didn't work," said Adam Bosworth, the chief technology officer at Keas Inc., whose clients include Pfizer Inc. and Novartis Inc. "If you keep giving someone negative feedback, they will eventually change the channel to the game channel. One day we decided to become that game channel." Bosworth was quoted in another Wall Street Journal article published today (see "Health Care Social Gaming Start-Ups").

So, which technology is better for helping people change their lifestyles and improve their health? Social media games or remote monitoring devices?

Which technology is better at helping change behavior & improve health?
	Mobile social gaming apps
	Mobile remote monitoring devices
	Both are effective.
	Neither are effective.
	I don't have a clue!

FDA Social Media Guidelines May Be Moot If This Court Decision Holds Up

Drugmakers dissatisfied with the FDA’s use of guidances as a form of policymaking -- including long-awaited guidance for use of social media by the pharmaceutical industry -- could find legal ammunition against the practice in the case "United States of America v. Franck’s Lab," which is pending appeal in the U.S. Court of Appeals for the Eleventh Circuit.

I noted before that the drug industry may be arraying its legal forces to derail the issuance of social media guideline (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media" and "Pharma Turns Up the Heat on Off-Label 'Free Speech' Chilled by FDA - Implications for Social Media Marketing").

The ruling being appealed is that FDA does not have authority to enjoin the "long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food producing animal by compounding from bulk substances." What can this possibly have to do with social media guidances?

According to a recent Washington Legal Foundation (WLF) "Backgrounder" (see "Court Ruling - If Upheld - Casts Doubt on FDA's Use of Guidance Documents"), "While Franck's case involved pharmacy compounding of bulk pharmaceuticals in non-food producing animals, its implications extend broadly to other areas of FDA law, particularly as it relates to FDA’s increasing use of guidance documents to expand regulatory requirements. In the past year, FDA has issued dozens of important draft guidance documents and final guidance documents, while releasing very few significant regulations. Given FDA’s penchant for issuing guidance documents instead of proceeding through notice and comment rulemaking, the court’s decision may have broad applicability concerning FDA’s ability to regulate or enforce its laws through guidance instead of rules. Indeed, FDA often applies draft guidance documents as if they represented binding obligations. It sometimes even references the contents of the document in communications with industry before the document is finalized."

WLF points out another reason the drug industry prefers rulemaking over guidance: "When FDA issues guidance documents," says WLF, "it tends not to acknowledge the negative comments. The agency typically offers no explanation for why it has opted to stick with its proposed language, rather than making changes to address adverse comments. This failure to respond to comments is not permitted for agencies when they engage in rulemaking [my emphasis]."

This lack of response to comments is a significant factor for social media guidance. The FDA held a public hearing and requested comments on the social media regulatory issues it proposed to write guidance for. Many, many comments were submitted (see "Answers to FDA's Questions Regarding Pharma's Use of Social Media") and so far the FDA has remained mum regarding these comments and may even do so when -- and if -- it publishes more social media guidelines. The recent off-label guidance (see "FDA Guidance on Responding to Unsolicited Requests for Off-Label Information Via Social Media") also did not refer to any comments the agency may have received.

"If the district court's ruling is upheld," says WLF, "its analysis on FDA’s use of guidance documents is likely to be cited in other FDA proceedings and legal challenges testing the agency’s right to enforce through guidance in lieu of regulations."

P.S. I note that the court case in question involved the death of several ponies due to a compounding error! PONIES! Lucky that it wasn't PEOPLE because I'm sure the court would not be so callous as to strike down FDA's rights in that case.

[Hat Tip to Darshan Kulkarni (see @FDALawyers and website) for providing information about this case.]

2011 in Images from Pharma Marketing Blog

These are my favorite images that appeared in Pharma Marketing Blog posts made in 2011. Enjoy and have a Happy New Year!

Pharma Marketing Blog: The Year 2011 in Images

View more presentations from Pharmaguy

FDA Guidance on Responding to Unsolicited Requests for Off-Label Information Via Social Media

Yesterday, while most of us were still on vacation, the FDA quietly issued without fanfare -- ie, no press release telling us about it or how to submit comments -- "Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices." You can find the document here.

Section VI. of this guidance addresses responding to unsolicited requests on public forums such as the Internet. While this may not be the "social media" guidance many people were expecting (see "First FDA Social Media Guidance to Address Responding to 'Unsolicited Requests' for Off-label Information"), it does include guidelines for responding to unsolicited requests for off-label information encountered through "emerging electronic media."

As with all guidances, FDA warns "Firms may choose to respond to unsolicited requests for information about off-label uses of their approved or cleared products in a manner other than that recommended in this draft guidance. Such activity would not constitute a per se violation of the law, but could potentially be introduced as evidence of a new intended use." Some drug companies (eg, Pfizer) would have preferred new legally-binding regulations rather than guidelines (see, for example, "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"). The industry might also challenge these guidelines on legal grounds (see, for example, "Pharma Turns Up the Heat on Off-Label "Free Speech" Chilled by FDA - Implications for Social Media Marketing").

Aside from pressure by the drug industry, FDA felt the need to issue this guidance because it "recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date information about the firm’s products." I'm not sure I agree with that because there have been a number of surveys that indicate physicians (as well as the general public) have several other preferred sources of drug information (see, for example, "Are Pharma Reps Important to Docs or Not?"). But let's leave that issue aside for now.

Let's take a closer look at how these guidelines apply to social media such as Youtube, Blogs, and Twitter.

The guidelines break out responding to PRIVATE and PUBLIC requests for off-label information. As for handling private requests, the guidelines pretty much reiterate what the drug industry already knows. The section regarding public requests, however, is what will be of most interest to the industry. Social media is in the this category.

Youtube and Solicited Requests
The guidelines have something interesting to say about videos posted on Youtube.  Specifically, it warns about responding to public comments that may be received in response to videos that a pharma company may encourage people to post about about their own uses of the company's product. FDA gives this example:

"A firm asks or otherwise encourages users to post videos about their own uses of its product on third-party video-sharing sites (e.g., YouTube), which may result in video postings about an off-label use of its product. If the firm’s initial request for posting of videos results in any questions about off-label uses, or if any off-label video posting made in response to the firm’s 1encouragement of video postings results in questions about the product’s off-label use, these questions would be considered solicited requests."

FDA considers requests for off-label information that are prompted in any way by a manufacturer or its representatives to be solicited. If a company responds to such "solicited  requests," it must be careful because such responses  "may be used as evidence of a new intended use. Introducing a product into commerce for such a new intended use without FDA approval or clearance would, under these requirements, generally violate the law."

Is this guidance enough to encourage pharma companies to open up comments on their Youtube pages?

I doubt it. Most pharma companies are still waiting to know how they should respond to potential adverse event reports they may receive via comments before they venture into opening up comments on Youtube. It's not even likely that pharma companies will engage in branded Youtube projects in the first place, although there has been a precedent (see "Novartis Attempts Perfect Execution of Web 2.0 Trick!").

Of more interest to me are the examples FDA gives for how drug companies should respond to "unsolicited" requests via social media.

Blogger Example of "Solicited Request"
FDA cites this example: "If a firm sends out packets of information to known bloggers or online consumer reviewers and encourages them to write about an off-label use of its product on third-party sites and this then provokes a discussion about that off-label use, any requests inquiring about the product’s off-label use as a result of these blogs, whether posted as comments to the third-party site or directed to the firm, would be considered solicited requests."

Although I have never heard of a pharma company ever "encouraging" bloggers to write about off-label uses, I do know that some companies have invited bloggers to vacation sites (see "A Call for Pharma Social Media Transparency Guidelines for Patient Bloggers"). What they discuss behind closed doors is not known to me or to the FDA unless there is a blogger "mole" present.

So, how would FDA prove that the company "encouraged" off-label discussion?

One way is to examine the contents of the "packets of information" sent to the bloggers. If that packet includes off-label information, then FDA can make a case that the company encouraged the blogger to write about it.  (See "BI Masters the Art of WOM through Its 'Parrots,' er, Spokespersons" for a similar situation involving BI). The guidelines do NOT get into this level of detail, which is unfortunate and supports industry's claim that FDA guidance is often "unclear." I'm sure this will be a topic covered by comments to the FDA regarding this guidance.

Twitter Example of "Solicited Request"
FDA cites this example: "If a firm announces results of a study via a microblogging service (e.g., Twitter) and suggests that an off-label use of its product is safe and effective, any comments and requests received as a result of the original message about the off-label use would be considered solicited requests."

Many pharma company Twitter accounts have been used to announce results of studies related to unapproved uses of Rx drugs. Some such tweets may have made efficacy claims, but I am not aware of any that claimed the product was "safe." I am not sure from reading the guidelines how FDA would view such tweets.

How should pharma respond to unsolicited requests received via public Internet sites and social media?

FDA puts limits on how to respond to such requests on public sites. FDA is concerned that product information "posted on websites and other public electronic forums is likely to be available to a broad audience and for an indefinite period of time [and] that firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information about FDA-regulated medical products to individuals who have not requested such information. In this circumstance, communications to persons who have not requested information may promote a product for a use or condition for which FDA has not approved or cleared. FDA is also concerned about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available)."

In general, FDA's position is that "a firm’s public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm’s contact information and should not include any off-label information."

That eliminates a "loop hole" I often worried about; namely, an anonymous agent of a pharmaceutical company can post a request for off-label information and initiate a discussion that includes information posted by the pharmaceutical company itself.

FDA suggests that a drug company handle such public requests through private channels after the requester follows up to the contact provided with a private request that will then be handled "offline."

FDA says:

• The firm’s public response should convey that the question pertains to an unapproved or uncleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information. 
• The firm’s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication.

Does It Serve the Public Interest?
Regarding responding to public requests; eg, via social media, FDA says "any substantive communication about off-label uses for the product, in response to the original unsolicited off label question, should occur solely between the firm and the individual who made the request," says FDA. "Regardless of the fact that the original, unsolicited off-label question may have been available to a very broad audience, the firm should not make its detailed response with off-label information publicly available within the same forum."

Unfortunately, although this may close the "loop hole" I mentioned above, this method of responding individually has a couple of negative implications:

1. First, private responses may not serve "the best interest of public health" because "public" means a bunch of people, not one person at a time. On the one hand, FDA believes responding to unsolicited requests for information about off label uses of the firm’s products serves the public interest because the firm has "robust and current information about their products." On the other hand, firms cannot distribute this information "publicly."
2. Responding privately requires more resources and expenses. Many people over the course of time may have the same questions. Instead of being able to use the power of the Internet to answer all these questions in a single message, each must be handled separately.

Sales and Marketing May be Seen, but Should NOT Be Heard From!
However the response is made, the FDA believes that "Responses to unsolicited requests for information should be generated by medical or scientific personnel independent from sales or marketing departments. FDA recommends that medical or scientific personnel have specialized backgrounds in responding to unsolicited requests for information, including important training, such as appropriately narrowing questions, tailoring responses only to the specific questions being asked, providing unbiased responses, and properly documenting responses.

"By contrast," says FDA, "because sales and marketing personnel are focused by training and experience on promoting a firm’s products, FDA recommends that sales and marketing personnel have no input on the content of responses to unsolicited questions or requests for off-label information."

There are more nuggets of information in this guidance that I haven't covered here. I look forward to the comments form the drug industry itself.

Webicina's "Open Access" Social Media Guidelines for Pharma

Health Social Media advocates abhor a vacuum, especially when the vacuum is caused by the lack of FDA guidelines for use of social media by the pharmaceutical industry. To fill that vacuum, several more or less independent 3rd parties are developing guidelines for the industry in the hopes of spurring the FDA to eventually do the same or to bypass the new for FDA guidelines altogether.

In the U.S., the Digital Health Coalition (DHC) is in the final stages of developing its "Social Guiding Principles," which is being shared with members of PhRMA who have expressed interest in the project. DHC's 7 dwarf-sized principles have been making the rounds to a select group of insiders and will be made public at the ePharma Summit in NYC this February (perhaps on my birthday!). See the PMN Conference Calendar for a link to the summit.

Another 3rd-party (ie. Peter Pitts) version of social media principles for pharma was previously reviewed by me (see "Deconstructing Pitts' Guiding Principles for Pharma Social Media"). Pitts created 11 principles. However, many of these principles may be very similar to the DHC ones if only because Peter Pitts worked with DHC.

Just recently, a third set of 3rd-party social media principles was released by my friend Dr. Bertalan Mesko (better known as @Berci), the founder and managing director of Webicina.com. These "open access" social media guidelines for pharma, which you can find here, were written by an adhoc editorial board of social media advocates with suggestions from "hundreds of collaborators." The authors are @Berci, Dr. Felix Jackson (@felixjackson), Silja Chouquet (@whydotpharma), Andrew Spong (@andrewspong), Denise Silber (@health20paris), and Rob Halkes (@rohal). It is a distinctly European group of experts, who hope their effort will "facilitate the process for the FDA of publishing its own guide."

Unfortunately, I don't think the FDA will be looking to an "open access" document for ideas. Also, in my opinion the "open access" SM guidelines, like the other two 3rd-party documents mentioned above, are much too vague to be of any use to the FDA. Still, I'd like to review the Webicina guidelines and see how they might be used by the pharmaceutical industry.

The Webicina document breaks down the guidelines into the following 8 categories:

1. A Physician’s Rules of Engagement 
2. Pharma’s Rules of Engagement 
3. How pharma should use social media 
4. How pharma should use Wikipedia 
5. How pharma should use Facebook 
6. How pharma should use Twitter 
7. How pharma should write blogs 
8. How pharma should use Youtube

Obviously, a lot of these "How To's" -- such as "speak plainly" and "be helpful" -- are not in FDA's bailiwick or not specific enough for FDA regulatory guidelines. I'll just look at what I think are the most interesting aspects of these guidelines, whether or not they are useful to the FDA.

Can Social Media Replace Face-to-Face Sales Rep and Physician Contact?
Under "Pharma’s Rules of Engagement," is included a few guidelines on how pharma should interact with medical professionals. It states, for example, "A private social media message is often as good as a face to face talk." In this context, I assume "face to face talk" means a visit by a pharmaceutical sales rep. Of course, personal contact between people will never be completely replaced by social media contact, but I can see how social media can save time and money if sales reps could communicate with physicians other than via office visits, which are pretty limited in the EU compared to the U.S.

But should pharma sales reps have their own Twitter accounts and should physicians "follow" these accounts and vice versa so that reps can DM (direct message) their physician clients? Maybe it would work. I'm sure that physicians would prefer short 140-character Twitter DMs over long email blasts! And these days, much commercial email ends up in the spam folder never to be opened!

People to People, Not Company to People Communication
Another suggestion put forward in this document is that when pharma companies use social media, they should "Be human. Ensure that you engage with people as people." I am an advocate of that idea and have been trying to "out" the humans who are working in pharma and who are using Twitter (see "More Pharma Social Media Pioneers Recognized"). But many pharma social media activities are completely non-personal and try to use the brand or company name as something real people will communicate with! It's not always easy to see who is "behind the curtain" and posting tweets or comments on Facebook. Sometimes, phony people are used to make the conversation seem more personal (see, for example, "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?"). That, of course, violates the main principle mentioned again and again in the Webicina document "Be transparent. Clearly state who you are and what your intent is."

For Facebook, the Webicina guidelines state: "Be clear: Provide information about the company with contact details and clearly state who publishes comments on behalf of the company. People prefer talking with a real person, not a brand or a company."

I see a problem with pharma companies getting too personal and allowing the person behind the curtain to be too visible. First, some companies (eg, Pfizer) claim that they do not have any people (FTEs) dedicated to social media. Several people may share the responsibility of posting tweets, for example. People also leave one company and join another. Nevertheless, I have given my Pharmaguy Social Media Pioneer Award to real people behind the curtain, not the company (see, for example, "AZ's Tony Jewell Receives 2nd Annual Pharmaguy Social Media Pioneer Award"). I just hope that it helps them when they look for a job with a competitor's company :-)!

Enable Comments, Don't Moderate?
The issue of comments on pharma social media sites is very problematic for the industry, which often cites regulations for why comments are turned off on sites like YouTube and until recently on Facebook. We've seen a number of instances where a pharma company has gotten in trouble because of  comments (most notably on Facebook; see, for example, ' "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page").

The Webicina guidelines, however, prefer that comments be enabled "where possible" (whatever that means). Furthermore, this principle of avoiding comment moderation is reiterated several times in the guidelines: "Avoid moderation. If you have to moderate, try not to pre-moderate and clearly state what you will moderate and why. Publish your moderation policy."

Pre-moderation, which the Webicina guidelines say may be OK fo blogs, is probably not something many pharma companies have the resources for managing. It may be something that is outsourced, though. Right now, however, it is an extra-added expense that many companies do not wish to have. Several comments form the industry to FDA's call for answers to its questions about social media favor post-moderation over pre-moderation (see "Answers to FDA's Questions Regarding Pharma's Use of Social Media").

Another, related principle: "Avoid editing comments. Do not edit the comments you moderate as it changes the meaning. People don’t like this. Remove the comment and explain why." This was another topic covered in comments to the FDA (op cit). It took less than 48 hours for Pfizer to explain why it deleted certain comments on its Chapstick FB page (see "Pfizer's Facebook Fiasco: Chapstick Slapstick Ad Uses Woman's Ass as a Prop"). That wasn't fast enough, however, to prevent a social media "death spiral" as reported by AdWeek.

Stop When Finished. Is a Campaign Socially Acceptable?
One interesting principle espoused by the Webicina guidelines is "Stop when finished. Close finished campaigns and redirect people to other places." In some pharma pundit circles, mentioning "campaign" and "social media" in the same sentence is as taboo as saying social media is "just another channel." Recently, I've criticized some pharma companies for abandoning their Facebook "friends" when new rules about comments were put in place (see "Pharma Facebook Pages Being Phased Out: A Good Run While It Lasted! Did Facebook Kill the Beast?").

I can see why pharma marketers prefer a campaign with a beginning and an end. They have specific budgets and must achieve a specific measurable goal (e.g, increased market share) within a certain time frame. There are other patient and physician needs that pharma can meet via social media that are NOT compatible with such a campaign mentality. Needs such as how to find affordable medicines, how to get more information about adhering to the treatment and other support issues. It's not clear who within a pharmaceutical company is charged with meeting such needs or if there is a budget outside control of the brand team for such things.

Wikipedia Editing Rules
On at least one occasion, a pharmaceutical company was caught editing a Wikipedia page about one of its products in order to gloss over some negative studies (see "Web 2.0 Pharma Marketing Tricks for Dummies"). @berci is an expert regarding publishing health information on Wikipedia, so I would take his advice (as it appears in the Webicina guidelines) seriously.

One Wikipedia editing guideline suggested is this: "Do not promote. Do not edit an article to promote your medicine." It may not be so easy to determine if the edit was done to help promote the product or to "correct misinformation." One person's idea of "misinformation" may differ from another person's -- especially if the other person is a marketer. Selectively adding only positive information (eg, positive results from new clinical trials) can be considered promotion -- in fact, it's what PR people (who are the pharma people in charge of social media activities) do all the time to "promote" their products.

Webicina offers a better Wikipedia editing principle for pharma: "Suggest edits. Suggest edits on the Discussion page for other editors to make. But you still need to be transparent about who you are and explain your rationale."

Rules for Twitter
Webicina et al have a couple of interesting rules for how pharma companies should use Twitter.

"Select your audience. Use different accounts for different audiences so that people can follow content which is tailored and appropriate for them. Examples include investors, shareholders, journalists, job seekers, patients and customers."

I haven't seen many pharma companies with multiple Twitter accounts, although I am sure there are a few. Some companies (e.g., Pfizer) may have different Twitter accounts in different countries. But most pharma Twitter accounts are corporate communications accounts that push out information to all the above-mentioned audiences in all countries. I haven't seen any that are just for patients, for example.

"Publish more than 140 chars. Use longer messages with services like Twitlonger to include additional information."

This is a good idea and one that I suggested some time ago (see "Breaking the 140-character Limit of Twitter Opens the Door to FDA-Compliant Branded Tweets"). I pointed out that this technique can allow pharmaceutical companies to make branded Tweets that will pass muster with the FDA. The "additional information" could be used to mention the brand name as well the important side effects as required by the FDA. However, I don't see this technique being widely adopted by any of the people or companies I follow on Twitter. I don't even bother with it myself.

You're Mad if You Don't Use Youtube
That's what the authors of the Webicina social media guidelines think, mostly because Youtube "generates the world's second largest number of searches after Google itself." Of course, that has nothing whatsoever to do with the merits of Youtube as a social media platform/channel or whatever. I have often said that pharma's interest in social media such as Facebook and Youtube has more to do with search engine visibility than with engaging in conversations (see "Drug Companies Are Flocking to Facebook for Eyeballs, Not Conversation").

It doesn't take a genius (or guidelines) to understand the appeal of Facebook, Youtube, and other social media platforms. This is where the "eyeballs" are as demonstrated by this chart from the 2011 PwC Health Research Institute Survey (click on the chart for an enlarged view):

I'm not surprised by the percent of consumers who have used Facebook, Youtube, and blogs to get health information, but I am bewildered by the "fact" that more people have used Google+ than Twitter for this purpose. I thought Google+ was dead in the water as a useful social media alternative to Facebook or Twitter. It could be that people chose Google+ meaning Google search because the latter was not an option in the survey. But I can see it now! There will be a rush to Google+ by pharma marketers in order to get in on the ground floor of another social media eyeball fest! In fact, I have heard that some companies are reserving Google+ account names without yet having any specific plans for how they will use it!

Proposed Rules for Physician Payment Sunshine Act: Some Clouds on the Horizon

The Centers for Medicare and Medicaid Services (CMS) released their proposed rule for the Physician Payment Sunshine provision of the Affordable Care Act (see "CMS Releases Proposed Physician Sunshine Act Regulations", where you can also download the proposed rule). Because CMS was late issuing this rule, the drug industry will NOT have to begin data collection on Jan. 1, 2012, as "required" by the Sunshine provision, and will not need to begin data collection until final regulations are issued. Final regulations come AFTER comments on the proposed rule are accepted through Feb. 17, 2012.

That means that only PART of the 2012 payments may be submitted on Mar. 31, 2013 and available for public scrutiny by Sep. 30, 2013.

It's possible, however, that CMS may be further delayed if the comments received are plentiful and difficult to respond to before the agency issues the final rule.

Of course, pharma companies by now should be ready to begin data collection by January 1, 2012. Which means that they could theoretically submit a full year's (2012) worth of data regardless of the timing of the final rule. CMS said "we recognize that some manufacturers and GPOs may begin to collect certain data voluntarily." How many companies, however, will do this when they can claim they were waiting for CMS? It's just another test of willingness of the industry to be pro-actively transparent and open.

Also, CMS is seeking comments "on the amount of time applicable manufacturers and applicable GPOs will need following publication of the final rule in order to begin complying with the data collection requirements." I anticipate that many comments might cite CMS's estimate of 90 days to be too little and request more time. Thus, we may not see any 2012 data at all!

CMS's Tardiness in Issuing Sunshine Act Rule May Mean We'll See No 2012 Data!
"Finally," says CMS, we also seek input on specific challenges that applicable manufacturers and applicable GPOs may face when setting up the necessary data collection and reporting systems."

This is the Achilles' Heel that may mean that we will not see any 2012 data at all! If drug and device companies cite significant challenges that CMS's final rule must mitigate, that could delay issuance of the final rule or significantly limit how the information is reported. The industry may claim, for example, that it is "challenged" to breakdown payments into specific categories and ask that payments be lumped into larger, more encompassing categories. This would make it more difficult to analyze the data to see exactly what physicians are being paid to do, especially research versus marketing assistance.

Here are some other tidbits from CMS's proposed rule:

Foreign Drug Companies Must Also Report Payments
CMS proposes that any drug or device company that sells or markets products in the U.S. are subject to the rule regardless of where their corporate headquarters are located. Thus, says CMS, "Under this definition, manufacturers of a covered drug, device, biological, or medical supply are deemed to be an 'applicable manufacturer' if their products are sold or distributed in the United States (U.S.), regardless of where the covered drug, device, biological, or medical supply is actually produced or where the entity is actually located or incorporated... The opportunity for undue influence or inappropriate relationships caused by payments or transfers of value to covered recipients is the same for manufacturers of drugs, devices, biologicals, or medical supplies sold or distributed in the United States regardless of where the product is actually manufactured, and we, therefore, propose to treat them the same."

"Common Ownership" Loophole Closed
CMS wants to be sure that a wholly or even partially owned subsidiary of a drug or device company set up to dole out payments to physicians cannot escape the regulation. Such companies under "common ownership" -- as when "the same individual, individuals, entity, or entities, directly or indirectly, own any portion of two or more entities" -- "are also subject to the reporting requirements under this provision, even though they themselves may not be involved in the "manufacturing" process." CMS is seeking comments regarding its definition of "common ownership" to see if changes are necessary.

OTC Drug Manufacturers Excluded
CMS's proposed rule excludes manufacturers/marketers of drugs and biologicals that are considered "over-the-counter" (OTC) from being covered by the regulations. "We believe that this exclusion may be appropriate for manufacturers that manufacture only these products (and not also products which fall within the proposed definition of 'covered drug, device, biological, or medical supply'), since physicians and teaching hospitals have less influence over patients' choice of OTC products."

Perhaps physicians have less influence over patients' choice of OTC products, but they surely play a role in Rx-to-OTC conversions. They sit on FDA advisory boards, for example, which determine if an Rx drug can be sold OTC.

Identifying "Covered Physicians"
There is some confusion on how to uniquely identify physicians. There are more than one "unique identifier" for physicians. The law refers to a National Provider Identifier (NPI) number, which is required under HIPAA.

CMS states "We seek comments on what other unique identifiers could be used, including whether these unique identifiers are readily obtainable by applicable manufacturers."

CMS is also closing a loophole I noticed in data already being reported by some drug companies; ie, certain payments are reported to be made to institutions or organizations rather than to individual physicians. CMS proposes that "payments or other transfers of value provided through a group or practice should be reported individually under the name(s) of the physician covered recipient(s)."

Categories of Information to be Reported
This is probably the most important issue that needs clarification. CMS provides details of how data such as names, addresses, medical specialty, date of payment, etc. are to be reported.

Name of Drug: The Sunshine Law requires that manufacturers to report the name of the covered drug, device, biological, or medical supply associated with that payment, if the payment is related to "marketing, education, or research" of a particular covered drug, device, biological, or medical supply.

"In cases when a payment or other transfer of value is reasonably associated with a specific drug, device, biological, or medical supply, the name of the specific product must be reported," says CMS. "For example, if a sales representative takes a physician to dinner to explain the benefits of the applicable manufacturer's new product, the name of the product must be included since it was associated with the dinner."

The Multiple Drug Conundrum
If the payment relates to multiple drugs, only one drug needs to be named. CMS, however, does not mention how the named drug should be chosen.

As an alternative, however, CMS is considering "allowing applicable manufacturers to report multiple covered drugs, devices, biologicals, or medical supplies as related to a single payment or other transfer of value. Allowing the reporting of multiple covered drugs, devices, biologicals and medical supplies may be easier for applicable manufacturers since many financial relationships are not specific to one product only, but would make aggregating payments by product difficult. We seek comment on this approach."

I'm betting the drug industry would prefer the one-drug naming approach where they have the option to name the drug of choice. This could make it difficult to link specific payments to specific drugs or assign payments to specific drugs to "even out" the distribution, Say, for example, that a sales rep is responsible for promoting 2 drugs at a dinner meeting, but is given a physician payment budget that apportions 80% to just drug A. The total budget could be reported under drug B, thus diverting attention away from drug A. I think you get what I mean!

Nature of Payment - Nondisclosure of Assumptions Make an Ass Out You and Me!
This is important. The Sunshine Act lists the following categories of payment:

• Consulting fees. 
• Compensation for services other than consulting. 
• Honoraria. 
• Gift. 
• Entertainment. 
• Food. 
• Travel (including the specified destinations). 
• Education. 
• Research. 
• Charitable contribution. 
• Royalty or license. 
• Current or prospective ownership or investment interest. 
• Direct compensation for serving as faculty or as a speaker for a medical education program. 
• Grant. 
• Any other nature of the payment or other transfer of value (as defined by the Secretary).

CMS suggests that manufacturers explain the reasoning behind how they categorize payments (in a mandatory "assumptions document") since there may be significant differences among manufacturers on this issue. However, CMS will NOT make these"assumption documents" public because "they may contain information applicable manufacturers would consider proprietary."

That's a pretty big "transparency loophole," IMHO. Although CMS will monitor the assumptions, there is no way for the public to monitor CMS! The drug industry can be free to define these categories as it sees fit and not run into trouble unless different companies use wildly different assumptions and raise red flags at CMS. Also, the politically-appointed HHS Secretary may overrule the CMS as she did with the FDA!

Also, the CMS is seeking comments on whether or not the "assumption document" submission should be mandatory or voluntary! I can only guess what industry's comments will be about that!

One Category for ALL Speakers' Fees
CMS does, however, specify how manufacturers should interpret "Direct compensation for serving as faculty or as a speaker for a medical education program." CMS proposes that this category be "interpreted broadly to encompass all instances in which applicable manufacturers pay physicians to serve as speakers, and not just those situations involving 'medical education programs.'"

Under that rule, accredited CME programs would be lumped in with all other speaking activities, such as satellite symposia.

"We are considering, and welcome comments on, whether to limit this category to CME-accredited speaking engagements and report other speaking engagements in another category, such as compensation for services other than consulting, or additional category."

I anticipate a lot of comments on this issue will be submitted.

There are many more proposed rules in the CMS document, which runs to 121 pages! I have gotten only as far as page 34 in this summary. I hope to publish a more complete summary with comments from experts in an upcoming issue of Pharma Marketing News (subscription required).

I invite you to submit comments to this post.

Pharmaceutical Representative Magazine Closes. Blame CafePharma!

"Pharm Rep Closes After 41 Years" is the title of parting editorial by Reid Paul, Editor in Chief of Pharmaceutical Representative magazine, which was trade publication focused on pharmaceutical sales.

"Nostalgia from my days 'carrying the bag' makes me sad to see this publication go," tweeted Mike Capaldi (@mikecapaldi), Associate Vice President at Sanofi.

"The reality is that pharmaceutical sales and marketing has changed dramatically over the past few years," said Paul. "It's more than a numerical decrease in the number of pharmaceutical sales professionals. The "traditional" sales role of the rep is rapidly evolving into something new and different that defies easy categorization. In the inaugural editorial, founding publisher Bill McKnight wrote, 'If salesmen really needed their own communication medium, then there must be enough sales managers willing to provide it through paid subscription.' While that may have been true in 1971, over the past four decades the publishing landscape has changed equally dramatically. Pharm Rep was one of the first, but now reps and execs have a broad range of options to communicate and find objective information on the industry."

Reps and execs certainly have a much broader range of communication options. As for reps, one of their favorites is CafePharma, an online discussion board for sales reps that is often maligned by pharma executives who have little time themselves for such frivolous activity! When Lilly's Deirdre Connelly described CafePharma as one of those "outlets for people who don't have the courage to speak out with their ideas," it didn't negatively affect her rise up the ranks (see here).

I'm thinking that other glossy print, paid subscription pharma trade publications will follow Pharm Rep down the worm hole of extinction.