Facelift or Saving Face?

February 7, 2007

Pharmaceutical Executive

Volume 0, Issue 0

FDA drug safety proposals don't represent major overhaul.

FDA's new drug-safety proposals that made front-page headlines last week illustrate the delicate dance that the agency is performing in an effort to please--or at least appease--its competing constituencies: Congress, industry, its own staff, and, last but possibly not least, the public. Pharma, for its part, won't find many surprises in the proposed initiatives, which are less agency overhaul than image booster.

The three umbrella proposals--essentially extensions of initiatives already underway covering science, communication, and management--respond to a scathing evaluation the agency got in September from the Institute of Medicine (IOM), which gave FDA failing grades in particular for its drug-safety monitoring.

The science recommendations are primarily an outgrowth of the Critical Path Initiative--the agency's ambitious attempt to modernize the pre- and post-approval by incorporating new tools like genetic screening, proof-of-concept studies, and high-tech adverse-event reporting databases. So, too, with communication--FDA is building on its "transparency initiative" launched in the aftermath of the Vioxx (rofecoxib) recall, when it pledged more direct communication with the public about drug risks. Finally, the management piece consists of hiring consultants to advise the agency on getting its staff--particularly its reviewers and drug-safety monitors, two distinct groups--to work more in sync.

"What's interesting [about the FDA's response to the IOM report] is not what it contains but what it doesn't contain," said Paul Kim, a food and drug attorney at law firm Foley Hoag. "It's a question of degree and it's a question of specificity and it's a question of language."

What the FDA reform doesn't contain is most of IOM's 25 sweeping recommendations--many of which have been trumpeted by senators like Michael Enzi (R-WY) and Edward Kennedy (D-MA). They called on FDA to undertake a major post-market safety-surveillance initiative, restrict consumer advertising, and include black triangles on new drug labels during a product's first two years on the market in order to alert the public that the drug lacks long-term data backing it up. Another recommendation called for mandatory disclosure of clinical-trial results in a public web database, to prevent industry from hiding negative results from scrutiny.

What industry doesn't want, however, is for the approval process to become so laser-focused on adverse events that it ignores the larger risk/benefit picture. "FDA realizes that they have to be out in front on safety," said Peter Safir, a partner at law firm Covington and Burling. "The bigger risk is that Congress is going to pass legislation" ranging from marketing restrictions to mandatory Phase IV trials.

Yet even these requirements are similar to those in countries like the Britain, and drug companies are likely to support--or at least pay lip service to--the changes. "These are global companies that think globally," Kim said. "This is not a threatening scenario." FDA also needs to have the teeth and the authority to compel compliance from companies.

But there's little question about the timing of FDA's proposals, which is all about the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA). In December the agency called for the PDUFA redo to the tune of $392.8 million, an $87.4 million jump. Congress is likely to rubber-stamp that amount but may tweak specific applications, according to Kim. As of now, FDA has directed the lion?s share of the increase--$29.3 million--toward monitoring drugs that have already received regulatory approval. Since FDA can only oversee treatments during their first three years on the market, the agency is also calling for more authority to assess safety throughout a product's life cycle.