Things to Look for in 2011

Well, everyone is either doing their look-back or look-forward thing.  The future is more interesting than the past, so here is the Eye on FDA list of things to look for this year:

  • Oversight, Oversight, Oversight – The FDA never has an easy time of it with Congress.  The agency is always in the cross-hairs of someone up on Capitol Hill, sometimes even with good reason.  With the switch in party majority for the House of Representatives, however, there is every reason to expect that the scrutiny of the agency is about to rev up a few notches.  That is especially true as we consider 2012 is already fast approaching.
  • Funding, Or lack Thereof… The Food Safety Modernization Act was passed and the President is due to sign it into law this week.  The law, which enjoyed broad support, provides the FDA with broad new authorities over food recalls and over food importation and represents fairly sweeping reform.  But in the end, we may just be asking ourselves “Where’s the Beef” as the user fee mechanism that would have funded the bill is not part of the law and with Congress intent on being stingier with dollars, when this bill becomes law, the flesh may be willing, but the wallet may be too weak to actually realize the aims and potential of the legislation. According to reporting in the Washington Post, Rep. Jack Kingston (R-GA), the new incoming Republican chair of the Appropriations sub-Committee is dubious about the case being made for the expenditure required to fund the law.  And, there is also the fact that the agency runs a tortoise-like pace when developing new regulations….
  • Social Media and Internet Guidance – And speaking of the slow pace of regulation development, the FDA missed its goal to issue a new draft guidance on the Internet and Social Media by the end of 2010 and issued a statement proposing a new goal for the first quarter of 2011.  That may or may not happen, though one would think it unlikely that they would set a second target they couldn’t make, however don’t look for the guidance to be complete – it will be partial – it will be draft and it will be based in principles, not platforms.  It won’t answer all of your questions about commercial speech by medical product manufacturers in today’s digital age.
  • Increased Enforcement in Social Media – The number of regulatory action letters by FDA has increased this year, and in particular DDMAC saw a healthy rise as well.  Given the continued expansion of the use of social media in the public discourse in general, and by medical product manufacturers in particular, and given the lack of a guidance, it is possible the agency will seek to define the environment in a more time-efficient manner.  The only avenue truly open for that is through the issuance of regulatory action letters that begin to identify when a practice has gone out of bounds – at least when it comes to the standards of print and broadcast media.
  • Biosimilar Regulatory Pathway – Actually this falls more in line with “Things NOT to Look for in 2011” but anyway – In November 2010, the FDA held a two-day public meeting to gather input into how the FDA should use the considerable latitude given by Congress in developing implementing regulations for a pathway for the approval of biosimilars in the United States.  The authority for FDA is outlined in the Biologics Price Competition Innovation Act, which is a subtitle of the Patient Protection and Affordable Care Act, otherwise known as health care reform.  When FDA issued its scheduled of guidance documents for 2011, absent from among the list was anything respecting the biosimilar pathway.  And, for the record, this weekend, one House Republican who happens to also be the incoming chair of the House Energy and Commerce Committee – Fred Upton (R-MI) expressed the belief that in the effort to repeal the law, there may be a veto-proof majority.  So, if you believe him, this may go off the radar screen entirely.

In the end, these are fairly obvious, but worth stating in one place, nonetheless.  Things have certainly shaped up to be a two-steps forward, one-step backward sort of environment.  I would go one, but no one likes long posts.  Happy New Year everyone!

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