New law expands FDA monitoring, funds

The multifaceted measure covers drug safety -- including stepped-up monitoring of drugs on the market -- children's special needs and food safety.

By Susan J. Landers — Posted Oct. 22, 2007

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Long-awaited resources to help the Food and Drug Administration more closely monitor the safety and effectiveness of the nation's pharmaceuticals and medical devices will begin to flow as a result of a comprehensive new law signed Sept. 27 by President Bush.

The Food and Drug Administration Amendments Act of 2007 reauthorizes the Prescription Drug User Fee Act, the Medical Device User Fee Act and laws that govern the safety of children's drugs and devices.

It also includes new measures that require the monitoring of massive databases to detect safety problems early, expand clinical trial registries and add a new public-private foundation dedicated to drug development.

The law was given "must-pass" status by Congress because without it, an important FDA funding source -- PDUFA -- was set to dry up at the end of September.

Congress also stepped in to help the beleaguered agency shore up its sagging reputation as the nation's pharmaceutical watchdog. Recent high-profile drug withdrawals had shaken public confidence in the FDA's abilities.

Sen. Mike Enzi (R, Wyo.), a bill sponsor and ranking member of the Senate Health, Education, Labor and Pensions Committee, praised the way the House and Senate worked together to gain the measure's final approval. But yet, "Is it a perfect bill?" he asked. "That never happens around here. Is it a big victory for patients and children? Yes it is."

Some specifics

The legislation ensures funding continuity by extending until 2012 user fee programs that allow the agency to collect millions of dollars from pharmaceutical and medical device manufacturers to speed review of their products. Both programs were to have expired Sept. 30.

In addition, the law increases by about $87 million a year the agency's user fees from pharmaceutical companies. This increase brings total PDUFA funding to about $392 million annually, said Randall Lutter, PhD, the FDA's Deputy Commissioner for Policy. He spoke at a briefing held after the president signed the law.

User fees from manufacturers of medical devices will also increase. The law authorizes fee increases of about 30% for 2008 and 8.5%in each fiscal year through 2012.

For the first time, some of the user fees will help pay for agency work in policing drugs and devices already on the market. The law also provides the FDA with new authority to address postmarketing surveillance, a responsibility that had previously been unclear. Now the agency will be able to require pharmaceutical companies to make label changes that reflect new safety information and to order companies to conduct additional studies or clinical trials for products on the market. The law provides for civil monetary penalties for violations.

AMA Board of Trustees Chair Edward Langston, MD, praised the law's safety provisions, noting that the measure "will help the FDA to better serve America's patients and physicians by providing the best methods to identify drug risks and communicate them to the public."

The law also encourages more accurate drug advertising. The FDA can now require companies to submit their direct-to-consumer television ads for review before they are aired, if there are safety concerns. The law includes heavier fines for running misleading ads. Some user fee funds will be dedicated to this review process.

"The reauthorization of PDUFA and MDUFA programs and their expansion will make sure the [agency's] centers have the additional resources they need for complex reviews of new drugs and devices," said FDA Commissioner Andrew von Eschenbach, MD.

It was also welcomed by Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, a Washington, D.C.-based group that represents many large pharmaceutical and biotechnology companies. "Since its original enactment in 1992, PDUFA has been a resounding success for FDA, pharmaceutical research companies, taxpayers and, most importantly, patients," he said.

The measure is also notable for what it doesn't contain. The AMA opposed a provision in an earlier version of the bill that would have restricted physicians' ability to prescribe certain medications.

Sen. Tom Coburn, MD, (R, Okla.) took action to ensure that the law preserves physician discretion in prescribing. "The AMA greatly appreciates Sen. Coburn's determination to ensure that physicians, rather than the FDA, are empowered to make appropriate risk/benefit decisions with their patients," said Dr. Langston.

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Drug safety law in the spotlight

The Food and Drug Administration Amendments Act of 2007 was signed into law by President Bush on Sept. 27. It reauthorizes:

  • The prescription drug user fee program through fiscal year 2012, with funding increases for post-market safety surveillance and the review of direct-to-consumer television ads submitted by companies.
  • The medical device user fee program through fiscal year 2012. Fees also will cover post-market safety checks.
  • The Best Pharmaceuticals for Children Act, which allows the FDA to grant an additional six months' marketing exclusivity to a manufacturer in return for FDA-requested studies on the use of the drugs in children.
  • The Pediatric Research Equity Act, which requires manufacturers to test drugs in children and label them appropriately when a company applies to market a new product.

It also:

  • Provides the FDA authority to require label changes on drugs and to fine companies that do not comply with requests for additional trials after a drug reaches the market.
  • Enacts the Pediatric Medical Device Safety and Improvement Act, which provides incentives to manufacturers to create medical devices specifically for children.
  • Creates the Reagan-Udall Foundation, a private, independent nonprofit group charged with modernizing drug development and exploring new ways to oversee drug safety.
  • Expands the existing clinical trials registry at the National Institutes of Health by requiring all trials on drugs, biologics and devices to be listed and that trial data be posted on approved products.

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