A New Way Forward for FDA?
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Last week, US Food and Drug Administration (FDA) Commissioner unveiled a “blueprint” that contained immediate and actionable steps that can be taken to spur innovation in the life sciences. The report’s proposals stem from a review of FDA’s current policies and practices, as well as months of meetings with major stakeholders nationwide, including key industry leaders, small biotech, pharmaceutical and medical device company owners, members of the academic community, and patient groups. Entitled “Driving Biomedical Innovation: Initiatives for Improving Products” the report focuses on seven major actions:
- rebuilding FDA’s small business outreach services
- building the infrastructure to drive and support personalized medicine
- creating a rapid drug development pathway for important targeted therapies
- harnessing the potential of data mining and information sharing while protecting patient privacy
- improving consistency and clarity in the medical device review process
- training the next generation of innovators
- streamlining and reforming FDA regulations
The blueprint was issued in response to growing concerns that—despite record investments in biomedical R&D—the drug pipelines at many US life sciences companies has grown exceedingly thin. Not surprisingly, most life sciences companies blame the agency for the thinning pipelines but in reality both side have contributed to the problem. Hamburg’s bold plan seems reasonable. But, it can only be implemented if Congress provides sufficient funding to underwrite the new initiatives proposed in the plan. And, while these funds ought to be allocated, it is not clear whether or not it is likely given the poor economy and the current, unprecedented political divisiveness that exists in Washington these days.
Moreover, Mark Senak, author of the Eye on FDA blog, suggests that FDA can improve its effectiveness by learning how to communicate better with its stakeholders. Mark, a social media advocate provides this compelling insight into FDA’s communication problems and the agency’s inability to grasp that the Internet and social media can help to improve its communication skills:
"The extremely long track record of FDA in attempting to figure out the Internet (first public meeting held in October 1996) and social media (first public meeting held in November, 2009) has yielded no guidance, with little transparency into the process. It is time for FDA to seek outside communications expertise to help the agency better formulate policy on a timely basis."
While I believe that Commissioner Hamburg’s blueprint for improvement is a good one, it isn’t clear whether she will get the necessary support to implement it.
Until next time...
Good Luck and Good Job Hunting!!!!!!!!
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Over the past few months, a 
Medicis Pharmaceutical, the maker of Dysport a drug approved by the US Food and Drug Administration (FDA) to smooth skin furrows between the eyebrows, recently
that AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistle blower lawsuits over the sale, marketing and off-label promotion of its blockbuster antipsychotic drug Seroquel. Despite this settlement, UK-based AstraZeneca still must contend with 14,444 civil lawsuits filed by many patients who developed diabetes and other health related conditions because of misleading marketing that failed to adequately disclose that the drug caused abnormal weight gain. 