After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.
Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews.
The current PDUFA law expires Sept. 30.
Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.
At least one amendment (S. 1082) that was successfully attached to the original legislation would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.
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 federal government can order manufacturers to conduct pediatric studies, but that almost never happens because the bureaucratic hurdles for making such a request are so high. The PDUFA reauthorization aims to streamline the process.
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 because it secured a promise from a group of senators to mark up 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 PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.