It is against this backdrop that a new administration-that of Barack Obama-takes office with the support of a left-of-center Democratic House and Senate. What can be expected with the Food and Drug Administration in particular?
The simple answer is that we are likely to see a more activist government and an increase in regulations and enforcement.
Several legislative proposals floated on the Hill last year may pick up speed this year, but in what form is difficult to say. When John Dingell (D-MI) was head of the House Commerce and Energy Committee last year, food safety legislation was his No. 1 FDA priority. However, having been dethroned by Henry Waxman (D-CA), food safety legislation could well take a backseat to other priorities.
If Congress does act on food safety, however, it will likely focus on inspections and traceability issues. Recent and recurring problems with imported food products have highlighted the need for better inspections at ports and overseas. Likewise, many believe that increased capability to trace foods through distribution will mitigate the spread of contaminated products.
Don’t be surprised to see a push to give the FDA and USDA mandatory recall authority. Right now, it is all voluntary by the company. Legislation will likely mandate company notification of a potential recall situation and agency authority to establish the parameters of the recall. And, depending on how that legislation is written, it could apply just as well to food packaging materials as to finished food products.
New FDA commissioner still uncertainBy the time you read this, the President may have nominated a new FDA commissioner. In any case, we’ll know a lot more of what to expect from the agency based on who is selected.
Names being bandied about include Joshua Sharfstein, a Harvard educated medical doctor who is currently the Baltimore Health Commissioner. He worked on the Hill as a staffer for Henry Waxman and is leading the Obama transition team’s assessment of the FDA, which certainly gives him a leg up. If Sharfstein gets the nod, expect him to come in as a reformer and an activist.
Another name is Steven Nissin, the well-respected chair of Cardiovascular Medicine at the Cleveland Clinic, who has been known to take drug companies and the FDA to task on safety and transparency issues. As a research scientist, however, he understands the contributions that can be made by all stakeholders in the process, including industry.
Though there is less chance of an agency insider getting the job, Janet Woodcock, the agency’s current director for the Center for Drugs, is a name heard often, as is former deputy commissioner, Mary Pendergast.
No matter who is chosen for the job, significant changes in the agency’s and industry’s responsibilities can be expected.