Senate OKs Medical Device Act for 5 More Years : Both the House and the Senate must move quickly to avoid layoffs and interruptions at the FDA.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

PDUFA would allow the FDA to collect $393 million in drug user fees in 2008, including a $30 million increase for postapproval drug safety programs.

The bill would also require drug makers to publish a registry of all late-phase II, and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would fund another 5 years of the Best Pharmaceuticals for Children Act. Companies that conduct pediatric studies of their products are eligible for additional patent life under the law, which expires Oct. 1. The new 5-year program will extend a drug's patent life by 3 months (instead of 6 offered under the previous law) if sales of the product are more than $1 billion and by 6 months if sales are less than $1 billion.

Under the Best Pharmaceuticals for Children Act, the Government Accountability Office found that drug sponsors have initiated pediatric drug studies for most of the on-patent drugs for which the FDA has requested studies. About 87% of drugs studied had labeling changes, often because the pediatric drug studies found that children might have been exposed to ineffective drugs or dosing; overdosing; or previously unknown side effects.

The Senate vote was hailed by the brand name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy, as it secured a promise from a group of Senators to markup legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The Generic Pharmaceutical Association also praised a group of senators who secured passage of an amendment requiring the FDA to move forward on generic drug applications even though a brand name company has filed a citizen's petition questioning the generic. In the past, the FDA has not been able to consider approval of a generic until the petition was resolved—and, filing a petition has become a common strategy used by the brand name industry, according to the GPhA.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.