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New federal law expands clinical trials database
Both device and pharmaceutical clinical trials will be affected by the new regulations.
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A sweeping new federal law will expand a national database to include information on clinical trials for drugs and devices.
President Bush signed the Food and Drug Administration Amendments Act in September. The law was expected to take effect by the end of 2007.
The law expands the clinical trials database, which can be found online at www.clinicaltrials.gov, to include trials on all drugs and devices, except those in phase 1 trials. The law will also increase drug and device user fees to fund additional resources needed to improve product safety review procedures, according to the FDA.
Pharmaceutical and medical technology advocacy groups praised the law after it was signed.
The Advanced Medical Technology Association (AdvaMed) said the law will benefit medical device innovation.
“AdvaMed and the medical technology industry would like to thank Congress for passing and the president for signing this key piece of health care legislation,” the release said. “This law is good news for every patient who depends on medical innovation.
In a news release, Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, praised the law as an effort to enhance drug safety.
 Julia C. Tierney |
“FDA will have the capacity to modernize its Adverse Events Reporting System, which is used to collect and aggregate safety data, enhance its use of epidemiology studies and large medical databases that contain a wealth of safety information, and better evaluate risk communication and risk management programs,” Mr. Tauzin said.
Attorney Julia C. Tierney, JD, who specializes in food and drug law at the Washington, D.C.-based law firm Arent Fox, said in an interview with Ocular Surgery News that her impression of industry’s reaction has been mixed.
“I don’t necessarily see great enthusiasm [on the part of industry], but I think that the bill is far less damaging than it could have been,” Ms. Tierney said. “Right now, they’re sort of scrambling to figure out how things are going to be implemented. … People are trying to establish what they need to do.”
The law will likely affect ophthalmology, a device-intensive specialty, Ms. Tierney said.
“I would assume that extending the clinical trial registry to devices would probably have an impact on ocular surgeons,” she said.
Transparency of clinical trial data
Under the law, industry will be required to publish basic information on trials and, within 1 year, publish trial results.
“This is quite a change from a few years ago, when there was a lot of criticism of industry for hiding the results of trials that had negative results,” Ms. Tierney said. “I think that this might restore some public confidence in the drug industry and device industry because there will be more transparency of the clinical trial process.
However, disclosing clinical trial information too early may not benefit industry’s interests in some cases, she said.
“I think that there is the risk that some information that would normally be kept confidential, because it’s in the early stages of drug development or device development, would become public, and that’s not good for the industry,” she said.
The law prohibits posting of information on device trials less than 30 days after FDA approval of a device, Ms. Tierney said.
“In that way, the device companies are able to protect their information a little more than the drug companies,” she said.
Still, the database will eventually include more information on clinical trial results for drugs, she said. “More and more information is going to be available about drugs potentially even before they are approved,” she said.
For more information:
- Julia C. Tierney, JD, can be reached at 1050 Connecticut Ave. NW, Washington, DC 20036; 202-828-3427; fax: 202-857-6395; e-mail: tierney.julia@arentfox.com.
- Matt Hasson is an OSN Staff Writer who covers all aspects of ophthalmology. He focuses on regulatory, legislative and practice management topics.