Buzz e-sante

The FDA’s long awaited social media guidance published in draft form early this year is long on reach and short on specifics; the largely negative reaction from the biopharmaceutical industry reflects this.

If you just read the headlines of the various government enforcement actions that have been brought and settled in the past few years, you are invariably led to conclude that biomedical drug and device firms are renegades who willfully ignore government oversight in pursuit of profits.  Of course they are in pursuit of profits, like all businesses, and therefore some regulation is important to ensure that truthful information is conveyed to patients, physicians and payers. But this very same regulation ought not preclude or inhibit manufacturers from providing the most current, accurate information available – who else but the manufacturer is more likely to have such information in the first place? I have written about this in the context of the off label promotion issue broadly, and I believe the same principle should apply to all forms of company communication.

Instagram and other Social Media Apps (Photo credit: Jason A. Howie)

With this in mind, a news flash that may not be evident to our public servants toiling away in the government bureaucracy: social media is a popular and increasingly important means of communicating information.  Shockingly, even doctors and patients use it.  A recent survey of physicians found that over 50% of practices responding used Facebook as a platform, and 87% those physicians under the age of 55 used some form of social media. With the Centers for Medicare and Medicaid Services (CMS) requiring increased use of digitalized data under the Meaningful Use guidelines, one might say that the government is actively encouraging certain actors in the healthcare system to increase their use of technology to enhance patient engagement.

But drug companies, not so much.  A study announced earlier this year by IMS Health found that only 23 of the top 50 global pharmaceutical companies made regular use of social media. A more recent survey by the Tufts University Center for the Study of Drug Development found that the use of social media in clinical research is minimal – so much so that most companies have yet to develop policies and practices in this area.  The survey found that only one in five firms that employ social media have used it to engage with patients, leaving it to third parties like patient advocacy groups or limiting their forays to banner advertisements.

The FDA’s recalcitrance in issuing guidance has been part of the problem. Back in 2008, when I held a visiting academic post at Oxford, I spoke with Jeremy Mean, the UK official who works with the British Medicines & Healthcare Products Regulatory Agency and is responsible for regulating these very same promotional and marketing practices by these very same companies.  In September 2007, now nearly seven years ago, he already had addressed formally an industry gathering to discuss the challenge of regulating social media communications.  He noted that while we know how to regulate labeling and promotional material, we are less certain as to how to evaluate “everything in between.” Still, even with this admitted uncertainty, Mean went on to discuss his preliminary views on web communications with industry representatives.  The FDA’s culture and history suggests that it is simply not willing to engage with industry in a collaborative effort to wrestle with the ambiguities presented by technological advance.  We are all the poorer for it.

Logo of the United States Department of Health and Human Services. The symbol represents the American People sheltered in the wing of the American Eagle, suggesting the Department’s concern and responsibility for the welfare of the people. The logo is the department’s main visual identifier; the seal is now used for mainly legal purposes. The color can be either black or reflex blue. More information here and here. (Photo credit: Wikipedia)

With its draft guidance, the FDA seems determined to put the genie back in the bottle, as it would make every utterance by a drug or device company subject to scrutiny to determine if it is outside the agency approved indication(s). Physicians have the prerogative to prescribe medications for unapproved uses, and often ask for guidance in prescribing and seeking reimbursement coverage for their patients, but companies are unable to freely advise on such issues other than in the context of a Medical Affairs representative responding to a specific inquiry from a practicing physician. Social media offers an opportunity for companies to provide background on medical practice and clinical developments, but the FDA’s draft guidance seems to go beyond the regulation of “labeling” or “advertising” as these terms are defined under the Food, Drug & Cosmetic Act (FDCA) to reach other types of communication.

Moreover, the guidelines raise the specter of the FDA expanding the scope of its purview to deem loosely or unaffiliated speakers as coming under the “influence or control” of the company – and therefore subjecting the company to liability for social media postings by a much broader range of actors than simply those who are authorized representatives of the pharmaceutical company’s Medical or Public Affairs groups.

This is touchy issue for many reasons, but just for fun, let’s wrestle with a philosophical question.  Should a company be held legally responsible for any actions taken or statements made by any and all employees and advisors that may relate directly or even tangentially to the company’s business?

Admittedly, corporations struggle with this question on their own. Most executives recognize that they cannot control their employees, particularly outside of the work environment. Yet they often hew toward a fairly restrictive position based upon heightened concerns of liability and government regulatory oversight. Some appear to cling to the belief, however outmoded, that management indeed can control the company’s message and reputation by controlling on line communications.

Here is a example of how some companies have approached the issue:

Although Public Affairs is solely responsible for developing and executing corporate communications on behalf of the Company, employees may post or engage in other social media activity on their own behalf outside normal working hours.  That said, it is important to acknowledge that employees who choose to do so may be seen as representing the Company, especially if the subject matter in any way relates to the Company, its business, its reputation, the science underlying our products and compounds, or public policy issues of concern to the Company or the biopharmaceutical industry generally.  As such, employees should avoid posting or engaging on social media outlets on a topic, or in a manner, that may reflect negatively on the Company.

In other words, we all know that we really can’t stop you from posting but . . . please please please don’t talk about the company. This has prevailed in many corners of the biopharmaceutical industry, where the rants of disgruntled sales representatives appear daily in living color on CafePharma, while the complexity of the safety and efficacy profile of approved drugs together with the limited space offered in some social media formats (e.g., Twitter) have handicapped efforts to communicate effectively with patients.

This is understandable, particularly as it concerns employees or agents who really don’t know what they are talking about.  But to the extent that corporate instincts are reinforced by an overly restrictive FDA, this is not necessarily a good thing.

Do we want to foster a dynamic marketplace of ideas where fulsome communication is supported?  Do we really believe that a government agency can – or should – control the information that is available to physicians and patients?  And if, in the company’s opinion, the posted information is wrong headed, do we want companies to act in good faith to correct the error?

 will watch with interest to see if the industry comments affect the final guidance. But the draft suggests that the agency is holding tight to a twentieth century command and control mindset, and is resisting mightily the sometimes uncomfortable reality of twenty-first century technology and its implications for healthcare communications.