OGD expects that GIVE will have positive results in the near term by providing for greater efficiency in document handling,
storage, and retrieval, among other improvements.
Bush Signs Bill Reauthorizing PDUFA
President Bush signed the FDA Amendments Act (FDAAA) into law on Sept. 27, thereby reauthorizing the Prescription Drug User
Fee Act (PDUFA). The act, H.R. 3580, will increase the agency's drug-safety authority, provide needed resources, and spur
FDA's Deputy Commissioner for Policy Randall Lutter said FDAAA allows the agency to collect at least $392 million in user
fees per year. The new amount is $87 million more than the previous level and effectively triples the user fees for postmarketing
safety surveillance. Lutter observed that PDUFA user fees make up nearly a quarter of FDA's total budget.
Reauthorizing PDUFA ensures "that our centers have the additional resources that are needed to conduct the very complex and
comprehensive reviews of new drugs," Commissioner Andrew von Eschenbach said. He added that FDAAA provides continuity for
many of FDA's important programs and "eliminates the possibility of significant, potentially very damaging, reduction" in
the agency's workforce.
The law also establishes the Reagan–Udall Foundation, a nonprofit organization that will assist FDA by modernizing product
development and stimulating innovation, according to Deputy Commissioner and Chief Medical Officer Janet Woodcock. The foundation
will identify unmet research needs and form partnerships with scientists.
FDAAA calls on FDA to set up an electronic surveillance system to track adverse events. It also requires companies to submit
postmarketing clinical-trial results to a database. Woodcock added that the legislation increases FDA's responsibility to
protect children's health by extending the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity
Act, which gives drugmakers an incentive to perform pediatric studies by granting six months of exclusivity.
See for more details on the FDA Amendments Act, in this issue.
European Fine Chemicals Group Issues Position Paper on Excipients
The European Fine Chemicals Group (EFCG, Brussels) issued a position paper on excipients used in pharmaceutical manufacturing
at CPhI Worldwide, held in Milan Oct. 2–4. Arnulf Heubner, chairman of EFCG's pharma business committee and director of pharma
and food raw materials at Merck KGaA (Darmstadt, Germany) outlined the group's position as it seeks to improve the quality
and regulatory aspects for excipients used in pharmaceutical products in Europe through the adoption of certain key proposals.
"By far the largest volume and weight of any medicine consists of a range of excipients, the manufacture of which varies,
is covered by limited regulation and lacks legal enforceability," said Heubner. "I am, therefore, concerned that by allowing
this situation to prevail we could be putting the health of European citizens at risk."
The EFCG outlined that with the implementation of the EU Directive 2001/83/EC (amended by Directive 2004/27/EC) into national
law, it is now mandatory that all active pharmaceutical ingredients (APIs), and the yet-to-be-defined list of "Certain Excipients"
used in pharmaceutical manufacturing, must be produced in compliance with current good manufacturing practice.