The Senate Health, Education, Labor and Pensions Committee has voted to 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 if sales of the product are more than $1 billion and by 6 months if sales are less than $1 billion.
An amendment to strip the patent-life-extensions was defeated.
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 Food and Drug Administration 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, according to the Health, Education, Labor and Pensions (HELP) committee, so an amendment was added to streamline the process.
In other drug matters, the HELP panel completed its version of the 5-year reauthorization of the Prescription Drug User Fee and Modernization Act, but generally without any restrictions on drug advertising or a requirement that most drugs have a risk management program—proposals that had been championed by Committee Chairman Edward Kennedy (D-Mass.) and his colleague Sen. Michael Enzi (R-Wyo.).
The two senators had been hoping to attach their proposals for improved drug safety to the Prescription Drug User Fee and Modernization Act (PDUFA) reauthorization, but most of their suggestions were defeated or watered down in committee.
The centerpiece of their bill was the risk evaluation and mitigation strategy (REMS) plan, which would have been required for all new chemical entities and biologics.
Instead the HELP committee voted to give Food and Drug Administration authority to determine when a new drug should have a REMS. The panel also voted to require FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety.
The bill “establishes a new way to oversee drug safety that is flexible enough to be tailored to each new drug, yet strong enough to allow decisive action when problems are discovered,” Sen. Kennedy said in a statement.
According to a statement by Sen. Enzi, the bill gives the FDA explicit new authority in the postmarketing area—which critics say the agency does not now have.
“Right now, the FDA has its hands tied behind its back when it tries to manage the risks of drugs already on the market.
“This bill will clarify and strengthen the FDA's authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americans, when the agency's postmarket surveillance signals potential dangers from a drug or therapy,” he said. “Pulling a drug from the market and denying patients who need it should not be the only tool available to the FDA.”
As passed by the Senate panel, 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 drugmakers to publish a registry of all late-phase II, phase III, and phase IV trials, and to make all trial results available in a public database.
The PDUFA legislation still has far to go before it becomes law. The Senate package will now go to the floor for a vote, and the House is still in the early phases of work, with the Energy and Commerce Health Subcommittee continuing to hold hearings.