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June 19, 2012  

House and Senate Negotiators Agree on Final Legislation That Would Weaken Medical Device and Drug Safety

Thanks to Work of Public Citizen, Other Patient and Consumer Groups, Legislation Avoided Some of the Worst Industry Proposals

WASHINGTON, D.C. – Legislation agreed to by lawmakers from the U.S. House of Representatives and U.S. Senate bows to the powerful interests of industry by weakening medical device and prescription drug safety, Public Citizen said today. The bill could be approved by the House as soon as tomorrow.

But after months of appeals to Congress identifying the dire threats to patient safety of some of the proposals in the original drafts of the bill, Public Citizen and other consumer and patient groups persuaded lawmakers to eliminate some of the most harmful provisions from the final version.  

The primary purpose of the bill is to renew and extend the Food and Drug Administration’s (FDA) programs for collecting user fees for prescription drugs and medical devices, fees that Public Citizen has long opposed but which the agency has become dependent upon to fund much of its critical regulatory work because of inadequate direct funding being provided by Congress. However, the bill includes many provisions unrelated to user fees that would amend medical device and prescription drug regulations.

“While the final bill includes some incremental improvements in comparison to earlier drafts of the legislation, the overall bill is littered with unnecessary and harmful giveaways to the medical device and prescription drug industries,” said Michael Carome, deputy director of Public Citizen’s Health Research Group. “Ensuring that the medical devices and drugs used to treat patients in the U.S. are safe and effective should have been the paramount goal of this bill. Unfortunately, the final bill agreed to by the House and Senate negotiators instead rewards industry and its highly paid lobbyists.”

One small improvement to the bill was a fix to an overly broad FDA secrecy provision that originally appeared in the House and Senate bills. The unwarranted secrecy provision would have permitted the FDA to withhold from the public all drug-related information provided by local, state, federal and foreign government agencies, so long as those agencies asked the FDA to keep the information secret. The current provision instead limits the FDA’s ability to withhold drug-related information to enumerated circumstances and covers only information voluntarily submitted by a foreign government agency. 

“The current language reflects a sensible compromise that goes a long way toward protecting public access to important drug and safety information while addressing the FDA’s concern that some foreign agencies might be deterred from sharing information,” said Julie Murray, attorney with Public Citizen.

The bill includes other provisions that would improve medical device safety by improving FDA’s medical device recall program. Butnumerous provisions successfully sought by the medical device and drug industry would negatively impact medical device and prescription drug safety. For instance, the bill would:

  • Place undue emphasis on FDA application of standards for clearing or approving medical devices that are least burdensome to the industry, further constraining the agency’s authority to seek important information relevant to the safety and effectiveness of devices, and pressuring the agency to take shortcuts to meet the demands of an accelerated review process.
  • Inappropriately constrain the FDA’s authority to disapprove requests from manufacturers to conduct research studies of experimental medical devices based on concerns about inadequate study design, thereby posing a potential danger to patients who volunteer to participate in such studies. 
  • Allow unlimited numbers of individuals to serve on FDA advisory committees who have substantial financial interests that could be affected by the committees’ advice, undermining the integrity and credibility of these committees in the eyes of the public.
  • Unnecessarily expand the use of the accelerated drug review process – which, among other things, relies on much smaller clinical trials – to a wider range of new drugs.
  • Provide five more years of monopoly protections for new antibiotics. Such monopoly protections will encourage companies to sell as much of the new antibiotics as possible, and thus conflict with the public health need to limit the use of new antibiotics, preserving them for serious resistant infections. Moreover, these provisions have the potential to promote antibiotics that are ineffective and unsafe.

Furthermore, Congress missed an opportunity to enhance medical device safety by failing to include in the final bill several commonsense provisions strongly endorsed by Public Citizen but opposed by industry. For example, the bill does not include the following:

  • A provision, known as “predicate nullification,” which would have closed a dangerous loophole in what is known as the 510(k) process that allows the FDA to clear a new moderate- or high-risk device for marketing based on its similarity to an older device already on the market, even if the older device upon which the clearance of the new device is based has been removed from the market because it has a defect that injures or kills patients.
  • A provision that would have prohibited the FDA from clearing class III medical devices – the most risky type of devices – and instead require the agency to review such devices under the more rigorous pre-market approval application process.
  • A provision that would have restored patients’ ability to seek compensation under state law for injuries caused by defective devices approved for marketing by the FDA.
  • A provision that would have given the FDA the authority to require, as a condition of approval of a new device, that the manufacturer conduct a post-market study regarding the device.

“Patients in the U.S. deserve legislation that strengthens the FDA’s review and oversight of these medical products to ensure their safety and effectiveness,” Carome said. “What they are getting is legislation that promotes the corporate interests and profits of industry by weakening such review and oversight.” 

For more information, please visit http://www.citizen.org/medical-device-safety-versus-corporate-profits.


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