May 24, 2012 ~ The U.S. Food and Drug Administration (FDA) is one step closer to being funded for the next five years in a bi-partisan vote considered good for the FDA and industry – but what about patients?
The Food and Drug Administration Safety and Innovation Act passed on an unusual bi-partisan vote, 96-1, with Sen. Bernie Sanders
( I-VT) voting against the measure which was set to expire this fall.
The new bill is being praised by industry, specifically AdvaMed which called it “good for the FDA; it is good for industry; and most of all it is good for American patients.”
One congressional staffer said both the pharmaceutical and medical device industries supported the bill because as he told American News Report, “the pharmaceutical industry wrote most of it.”
The five-year reauthorization of FDA user fees amounts to $6.4 billion and helps fund the agency’s review of medical devices and drugs including generic and biologic drugs.
Those who observed the vote were amazed at how fast it passed. Consumer Union’s (CU) Lisa Swirsky, a policy analyst with the group said CU was deeply disappointed that the premarket review of medical devices was not made tougher.
AdvaMed’s version of ‘good for patients’ translates to bringing medical devices to the market faster. In agreeing to a doubling of the FDA budget for medical device reviews from $295 to $595 million over the next five years, industry expects something in return from the federal watchdog agency.
The FDA will be required to agree to a series of performance goals and changes in device review protocol working in concert with industry. Besides AdvaMed, the Medical Device Manufacturers Association and the Medical Imagine & Technology Alliance backed the measure.
In February, a spokesman for Medtronic told MassDevice “A strong and adequately resourced FDA is necessary to sustain public confidence and to achieve a more transparent, efficient and accountable regulatory approval process for the innovations we bring to patient care.”
In other words – industry will guide the FDA to a timeline for medical device approvals in order not to “stifle innovation.”
In February, Consumers Union (CU) brought eight patients to Washington D.C. to meet with lawmakers and press for more FDA oversight over devices, not faster approvals.
The group’s Safe Patient Project believes the FDA budget is more focused on serving industry than patients. The public is increasingly being harmed by defective defibrillators, surgical mesh and metal-on-metal hips that have been put on the market through a safety loophole, the 510(k) within the FDA that allows a medical device to be approved after naming a “predicate” already being sold, even if that predicate has been recalled over safety issues.
The design flaw would not have to be fixed before using it as a predicate, again and again. More than 90 percent of medical devices make it to market after they claim to be “substantially equivalent” to a predicate device.
In a statement issued today, May 24, the consumer group outlined the patient safety provisions missing from the Senate bill:
Prohibition on clearing new devices based on recalled devices: The Senate bill does not include a provision preventing medical devices with known safety problems from being used as the basis for clearing new devices. Under the FDA’s 510(k) process, the agency has to approve a new device if it is substantially equivalent to one already being sold, even when the new device is based on one that has been recalled by manufacturers due to safety problems or has a recalled device in its lineage. Currently, the FDA does not even have the authority to require manufacturers seeking clearance for new devices to demonstrate that they have addressed the flaws of the recalled device.
Consumers Union has urged Congress to prohibit recalled devices from being used as predicates for new devices. An April Consumer Reports poll found that 71 percent of Americans believe that a new medical device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.
A national registry for tracking medical implant problems and notifying patients: The FDA does not have all of the tools and resources it needs to adequately track and evaluate how patients with implants and other high-risk devices are faring. While the Senate bill includes some improvements in this area, it does not address the need for creating a national registry of patients with devices, which would help the FDA more quickly identify problem devices and notify patients when their device has safety problems or has been recalled.
Stronger authority for the FDA to require post market studies: The Senate bill does not give the FDA the authority to rescind clearance of a device when a manufacturer fails to comply with an order to conduct a 522 post-market safety study (that is ordered because of harm to patients) or when a post-market study reveals safety and effectiveness problems.
Retaining Existing Conflict of Interest Standards: The Senate bill weakens current standards for preventing conflicts of interest on FDA panels that review medical devices and prescription drugs. The bill eliminates existing limits on the number of waivers the FDA may grant to experts with financial ties to the medical device industry. These limits were championed by consumer advocates and adopted by Congress just five years ago. The Consumer Reports poll found that 66 percent of Americans had a high level of concern about the safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.
Consumers Union says the Senate bill does include some improvements, among them:
*a provision that allows the FDA to classify problematic devices so others that follow receive more scrutiny
*Allows the FDA to conduct post-market 522 studies when a safety issue has been identified, however manufacturers are allowed to delay beginning those studies for 15 months
At the behest of the medical device industry, Sen. Orrin Hatch (R-Utah) had tried to tie MDUFA to a repeal of the medical device tax of 2.3% that industry has long opposed. The effort was dropped but Sen. Scott Brown (R-Mass) said he would try and suggest another amendment calling the medical device fee a “job-killing“tax.
A House version of the bill has yet to go to a vote but could go as early as May 30 after the Memorial Day recess.
Sen. Sanders said in a statement that his lone vote of dissent was because the user fees do little to address the prescription drug system that fails the American people. “The most pressing prescription drug issued in our country today is that Americans pay, by far, the highest prices in the world for the medicine and millions of people cannot afford the medications their doctors prescribe,” Sanders said in a statement.
Sanders wrote an amendment that was also defeated. Citing a “culture of fraud” in the pharmaceutical industry, it would have taken away exclusive marketing rights if a drug maker was found guilty or admitted to committing fraud in marketing a medication. That measure failed on a 9 to 88 vote. #
Politico – FDA user fee bill passed by Senate
MDND, May 14, – FDA Closer to Funding Goals – Where is Patient Safety?
American News Report, May 24 – Senate Passes FDA User Fee Bill