Washington Editor

President Bush on Thursday signed the Food and Drug Administration Amendments Act, a bipartisan bill passed by Congress last week that gives FDA new authorities and funding. (See BioWorld Today, Sept. 20, 2007, and Sept. 21, 2007.)

The act reauthorizes the Prescription Drug User Fee Act, the Medical Device User Fee and Modernization Act, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, which were set to expire Sunday.

The new law also expands the FDA's post-marketing surveillance powers and triples the agency's budget related to those activities.

During a media telebriefing Thursday, FDA Commissioner Andrew von Eschenbach noted that the act contains about 200 specific provisions. Regulators told reporters that the agency is uncertain whether those provisions will be self-implementing or if the agency will need to draft guidelines or regulations to implement certain measures in the new law.

"All of our regulations and guidances would go through the normal procedure of public comment," said Randall Lutter, FDA's deputy commissioner for policy.

However, the process of drafting regulations and seeking public comment often can be arduous.

For instance, Congress passed the Prescription Drug Marketing Act (PDMA) in 1988, but it took more than a decade for the agency to draft and implement regulations for some of the provisions, particularly rules that govern how drug products bought and sold among manufacturers and wholesalers are tracked - the pedigree rule.

After finally implementing final regulations for PDMA in 2000, the FDA imposed a six-year stay on its own pedigree rule while it worked out concerns raised by internal lawyers, lawmakers, drug manufacturers and distributors about the rule's language and how the regulation should be enforced.

In December 2006 - nearly two decades after PDMA was enacted - the FDA lifted its stay and issued a compliance policy guide that clarified the pedigree rule.

Many of the provisions in the new FDA law have timelines for implementation specifically stated in the legislation, von Eschenbach noted.

"We will be approaching this very systematically and very thoroughly, and there are clearly some things that we believe we will immediately be able to address," he said. "The complexity and the challenge is in the comprehensiveness of this bill and its many important provisions."

However, Lutter added, the FDA will "have to answer the specifics about what would be needed to implement any of those new authorities or related provisions a little bit later on after we have figured more details about an implementation plan."

No Comments