Jim Weinrebe

FDA Social Media Hearings: Day 2

As two jam-packed days of testimony near a conclusion, one powerful theme continued to resonate from drug and device companies and associated vendors: If emergent FDA regulations on participation in social media are so onerous that they serve to deter drug and device makers from being in this arena, the commercial stage will be entirely left to unregulated entities including marketers of alternative health remedies, off-shore pharmacies peddling potentially counterfeit or unapproved therapies and a tidal wave of law firms provoking panic about branded Rx products in an effort to recruit vulnerable consumers for class action lawsuits. This result, it is argued, creates a vacuum that would leave  the Internet the sole commercial province of companies whose messages and products aren't validated via clinical trials or accountable in any way to the FDA.

The Agency was repeatedly implored to collaboratively identify and establish responsible but practical, realistic ways to enable responsible industry participation in social media. Among the oft repeated suggestions was for FDA to recognize that regulations must be tailored to the unique technology attributes of social media channels and tools, and mindful of the staggering volume of content generated every second.
Vehemently crusading against allowing industry to more easily participate in social media was a spokesman from Consumer's Union, who warned FDA to not repeat what he asserted has been the dire consequence of DTC advertising in traditional media. The Internet, the spokesman warned, only offers more opportunity for deceptive and sinister marketing practices by an industry that he apparently believes is not to be trusted.

Social media, industry argued, could actually help FDA better achieve its public health and safety mission with respect to effective communication with the public. Current regulations mandating  comprehensive detail of all labeling and safety information, regardless of format, it was stated, result in a blur of fine print or voice-over garble that nobody can read, hear or understand. It was argued that these regulations serve as more of a legal mandate than an effective  communications mandate.

Through Its interactive, linking, searching and click-through capabilities, industry advocates contended, social media offers tools and formats that could be mobilized by companies and FDA alike to establish a new paradigm for communicating accurate and understandable health  information in a simpler and more accessible way to the public.

Many terrific, specific suggestions were illustrated. One can only hope the FDA was truly listening.

Posted by Lloyd Benson on November 13, 2009 at 3:36 PM
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Adverse Event Reporting Commentary Leads Day 2 of FDA Social Media Hearings: MedWatch a Focal Point

From Jim Weinrebe, live from the hearings:

Look for MedWatch to become an increasingly "go to' website for consumers experiencing problems they believe are associated with their prescription therapies.

We're barely 30 minutes into the morning's agenda  on what Internet regulations should exist for adverse event reporting, and two speakers have already spotlighted the need to make the MedWatch site more consumer-friendly and accessible. One speaker represented Consumer's Union, and the other was a woman whose husband commited suicide after taking anti-depressants that were associated with the potential for suicidal tendencies.

Both speakers urged FDA to actively promote the MedWatch site to consumers, with one noting that most consumers aren't even aware of its existence and what it's used for. Promotion of MedWatch should be supplemented by modifying its language and process to facilitate easier use by consumers in the reporting of adverse events, the speakers both noted.

The Consumer Union spokesperson stated that manufacturers should be required to post prominent links on any website not only specific to a branded drug, but also non-branded disease awareness sites controlled by the company and even third party group websites of which the manufacturer is a substantial sponsor.

Looking down the road, highlighting MedWatch and facilitating links to the site appear to be a likely point of consensus among all parties. It makes a ton of sense from both a public health and industry reporting burden perspective. More to come.

Posted by Lloyd Benson on at 10:06 AM
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FDA Social Media Hearings Part Deux: TO MONITOR OR NOT TO MONITOR? AND WHAT'S UP WITH GOOGLE?

One of the most strongly, consistently stated tenets about social media is that if a company does nothing else, it should at least actively "listen." But for regulated drug and device companies, what if listening and monitoring yields mountains of hard to vet, potentially adverse event information that must be reported? Or uncontrolled consumer discussion and posting of off-label use of regulated drugs and devices for which a manufacturer could theoretically be held accountable? 

If comments from presenters and questions from FDA at today's hearings are any indication, there will be a glacier-like but inevitable move toward policy that codifies the "safety" of active listening and monitoring without a corresponding and untenable burden of accountability for Internet "policing" beyond what a manufacturer has created or sponsored.

There were several suggestions for FDA to define what could be constituted as "best effort" for monitoring and reporting. What will that be? Stay tuned but don't hold your breath.

Similarly, industry presenters repeatedly recommended prominent use of links within manufacturer-controlled content to the FDA web site where product-specific safety and labeling information resides, and also to the MedWatch site where adverse events can be officially reported.

It was abundantly clear that industry -- not FDA -- will lead the regulators to viable solutions.

Meanwhile, wrapping up the day was Google, which in a remarkable display of audacity didn't utter a peep about SideWiki. Go figure. Good thing for Google it was the end of a long day and people were in no mood to linger and interrogate.

Posted by Jim Weinrebe on November 12, 2009 at 9:44 PM
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Commentary on FDA Hearings on Social Media

From Jim Weinrebe, EVP at Schwartz Communications, live from the FDA open hearings on use of the Internet and Social Media Tools in Promotion of FDA-Regulated Products:

Four hours of testimony has just concluded, with statements from product manufacturers and their trade associations, communication firms, lawyers and non-profits and health advocates. As suggestion after suggestion piled up as to what industry and FDA can or should do to find an acceptable middle ground between industry participation in social media and realistic regulatory requirements for monitoring of and accountability for correcting inaccurate information, one fundamental question loomed un-stated. That is, until the very end of the morning session: How can an already capacity-constrained FDA that struggles to expedite its current mandate possibly find the organizational funds and staffing to take on all the activities associated with social media monitoring and policing? The firm recommendation from Diana Zuckerman, representative of  the National Research Center for Women and families and a harsh industry critic, is to institute user fees for that very purpose. A formal proposal toward that end is pending, according to Zuckerman, who also "outed" several product brands and companies for Internet communication that she alleged was lack of compliance with existing requirements for risk disclosure. Certainly a wake-up call and provocative way to end the morning.

Posted by Jim Weinrebe on at 1:14 PM
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Schwartz Team at BIO 2009

Lauren Arnold, Joe Pacheco, Jim Weinrebe, Jayme Maniatis and Kristina Ebenius at the Biotechnology Industry Association (BIO) annual conference in Atlanta. Welcome to booth 4715!

Posted by Jim Weinrebe on May 19, 2009 at 11:55 PM
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BIO 2009: Despite Bleak Economy, Optimism Still Flows

Attendance is down at this year’s international BIO conference and many of the clinical stage attendees are in a frantic race against their respective burn rates, but this event once again distinguishes itself as a forum where many of the industry’s best and brightest convene to be passionate about their science and its life changing potential, despite the formidable odds faced by so many. And while Big Pharma stalks the aisles and presentations looking for the next hidden gem that will restore luster to their aging portfolios, it is, once again, the little guys who really shine as the sources of innovation.

What has changed are the business models and pipeline strategies. They are far more practical in outlook and expectations than ever before. Projects of real scientific merit but commercially less within reach are being shelved in favor of more focused business strategies. With sharper focus on fewer projects, but ones with nearer term potential, these companies are operating with far more operating savvy that will help them weather the storm.

Big Pharma would be wise not to approach this as a buyer’s market. Even a biotech on the brink of running out of cash may have the cure that ails their portfolio. This is a more sober, more realistic partner match making environment where it is advisable to tread carefully.

Posted by Jim Weinrebe on at 11:30 PM
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Biotech Entrepreneurs Must Be Heard in Biosimilars/FDA Regulatory Pathway Debate

Have we at last reached the point where U.S. lawmakers finally establish an FDA regulatory pathway for follow-on biologics?  The Zeitgeist says it is so.  You can feel it, see it, hear it and know it. There is just way too much hurting in this economy and far too much of a mandate for healthcare reform for political gridlock or inertia to win out.

And now, as they say, the Devil is in the Details, because we have a plethora of competing bills to debate. If the stars are aligned, H.R. 1548, the Pathway for Biosimilars Act and a forward-thinking piece of bipartisan legislation co-authored by Representatives Anna G. Eshoo (D-CA),  Jay Inslee (D-WA) and Joe Barton (R-TX) will be the result. H.R. 1548 is a win-win-win for patients and families who desperately need more affordable access to safe and properly-manufactured life-saving biologics, for payers and employers seeking to cut costs, and for an industry whose innovation and high-wire risk-taking can’t even exist if investor incentive is squelched.

With some kind of regulatory pathway seemingly inevitable for follow-on biologics, the stakes are higher than ever to make sure that H.R. 1548 or some reasonable facsimile emerges. Industry would be wise to more prominently feature the voice of clinical stage biotechnology companies and entrepreneurs in this debate. Early evidence suggests this may not be happening enough. Too many of the press releases and op/ed’s on this issue are being churned out by the global giants, cultivating an impression that the biotechnology industry and Big Pharma are one and the same. While consolidation, M&A and licensing agreements have brought about de facto convergence, we should know by now that Big Pharma’s voice doesn’t  evoke much sympathy in the Court of Public Opinion.
 
But winning this battle isn’t just a matter of clever scripting and casting for a lobbying campaign. Entrepreneurial biotechnology companies will always be the most bountiful source of innovation in this industry. The potential for significant therapeutic advances depend on them. Big Pharma needs them for aging pipelines. It’s a daunting landscape right now for these companies. About one-third of them only have six months of operating cash left. Seed and venture capital are drying up. Investors and partners are increasingly opting out of deals and walking away from projects both early and late.  The Public Markets are a non-starter. The wrong kind of FDA regulatory pathway could make this group even more of an endangered species by discouraging early stage investment in these most highly speculative ventures. The regulatory pathway debate must be as much about preserving innovation as it is making biologics more affordable, and industry is certainly “on message” in this regard but Big Pharma just isn’t the best messenger.

If industry doesn’t want the regulatory pathway debate to succumb to the political grandstanding tactics that are always aimed at the drug industry, then it must galvanize the voices of innovators, not just big marketers. Biotech entrepreneurs have the most authentic and sympathetic voices to define what separates biotechnology from pharmaceuticals in terms of innovation, the complexities of safely replicating therapies, the cost of discovery, R&D and materials, the uncertainty of survival and why there’s a need for a Pathway that provides longer-term protection of IP for biologics in the first place. 

For their sake – for everybody’s sake – it’s time for industry to help these voices be more forcefully heard.

Schwartz will be at the International BIO Conference in Atlanta so please stop by our booth #4715 to chat if you'd like to.

Posted by Jim Weinrebe on May 5, 2009 at 4:15 PM
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