FDAnews Drug Daily Bulletin

Kennedy Introduces PDUFA Reauthorization; Bill Alters Pediatric Exclusivity

April 16, 2007

Sen. Edward Kennedy (D-Mass.) introduced the Prescription Drug User Fee Act (PDUFA) reauthorization last week, proposing a new structure that would increase the agency's user fees by more than $100 million.

The bill, "The Food and Drug Administration Revitalization Act," S.1082, was referred to the Senate Health, Education, Labor and Pensions (HELP) Committee April 10.

User fees totaling $393 million are authorized under the proposed legislation, up from $259 million for fiscal 2007. The increase includes approximately $30 million in additional user fees for "postapproval drug safety programs."

The bill also modifies the "Best Pharmaceuticals for Children Act" (BPCA) by reducing pediatric exclusivity for blockbuster drug products. The HELP Committee discussed modifying BPCA's pediatric exclusivity provisions at a recent congressional hearing where Sen. Chris Dodd (D-Conn.) referred to incremental profits manufacturers gain from the additional exclusivity as "windfalls."

Under the proposed legislation, pediatric exclusivity for drug products with annual sales of $1 billion or more would be limited to three months, although products with less than $1 billion in sales remain eligible for six months of exclusivity. The original BPCA is set to expire in September, along with PDUFA.

According to Kennedy, the PDUFA reauthorization would also streamline the administrative process if the HHS secretary decides to require manufacturers to submit pediatric data, even when they do not take the exclusivity.

The legislation would also require that approvals for drugs and biologics take into account "risk evaluation and mitigation strategies," which would be reviewed annually for three years. The minimal requirements for these risk management programs include: FDA-approved professional labeling; 15-day, quarterly and annual reports of adverse events; routine active safety monitoring; and a timetable for periodic assessment of the risk management programs, according to a summary of the bill.

( http://www.fdanews.com/did/6_74/ )