Clouds on the Horizon, Part 3

J0399655 Every so often, I think it is a good idea to take stock of the current environment and assess the opportunities and challenges that lie ahead for both the FDA and for industry.  Right now, there are a LOT of them, some of which I’ve talked about before, but which appear closer than they were yesterday.  For example:

The Donut Hole – Inside the questionably designed Medicare Drug Benefit is the much heard about donut hole.  It is estimated that the first wave of seniors should hit it just before election time.  That could mean

  • calls to reform the Benefit greet the new Congress being elected.
  • that many seniors vote for those who promise reform. 
  • that a spotlight falls on industry shortcomings in supporting seniors through that time and therefore, it is a good idea to polish off patient assistance programs and be ready to talk to seniors about helping over the donut abyss, and
  • renewed focus on Canadian drugs as those in the donut hole look to foreign markets cheaper prices to help them out, perhaps even (as mentioned last week) creating an environment of more aggressive advertising by Canadian pharmacies.

FDA Reform and PDUFA Renewal – Given that the FDA continues to be mired in crisis and seems to be heavily invested in doing nothing about it, FDA reform of some kind appears inevitable.  There are a lot of legislators chomping at the bit to bring reform (notably Senators Kennedy and Enzi) and some who just enjoy the theatrics of repeatedly using the FDA as a grandstand (notably Senator Grassley) for publicity. 

However, there are real problems for the agency not only on the Hill, but in the minds of the public.  So far, the communications efforts of FDA to help shape that opinion appears without message or strategy.  For example, Dr. von Eschenbach gave a recent speech that was posted on the FDA Web site regarding the 100 year celebration of the agency.  While it was a true breakthrough in that he was able to actually focus on the impact that pharmaceutical advancement means to the life of a patient, there is still a far way to go for FDA messaging.  In any respect, at least his sppech was a departure from one he gave before the Center for Medicine in the Public Interest (not posted to the FDA site) during which he spoke for a long time and said almost nothing.  Nature hates a vacuum and given important legislation aimed at reform of the agency as well as PDUFA, a lot could happen to negatively affect the agency and the industry.

  • The agency is being asked to do a lot more in reform – including enforcing post-marketing trials.  The poor track record of Phase IV performance is going to be a club by which industry and the agency are beaten.
  • In being asked to do more, the agency will need more money from industry in the form of PDUFA fees.  That will prompt some consumer groups to further raise their voice that the agency cannot regulate an industry from which it receives the bulk of its budget.  That club will remain as potent as ever. 
  • Bad poster boy practices are going to be dredged up to show as examples of companies in need of greater regulation.  There is going to be an effort to showcase "worst practices" around FDA and industry conversation, generic competition, DTC, marketing practices, sales force practices, adverse event reporting and of course, Phase IV trial commitments.  Take stock and prepare. 
  • Incidentally, expect that with the recent increase in criticism and scrutiny on the number of warning letters issued by the agency, it is a distinct possibility that the number of such warning letters will begin to increase – especially if Democrats recapture the legislative branches. 
  • The election cycle will provide a showcase and platform for all of this. 
  • PhRMA, like FDA, appears to be in a stupor on the strategic front with no sign of emerging from it.  (See last week’s posting on DTC)

The bad news is that the policy environment will continue to be focused on risk over benefit, meaning that policies that come forward will be designed to curb risk while doing very little to support the benefits of pharmaceutical product advancement.  The good news is that there will be significant advancement in spite of the failures of the stakeholders involved. 

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