June 19, 2012
And Some Measures Opposed By Consumer Groups
WASHINGTON, D.C. — Key leaders in the House and Senate have reached an agreement on a revised version of the FDA User Fee Act. The bill includes some patient safety provisions from the Senate-passed version of the legislation that will help improve FDA oversight of medical devices while adopting some measures that were opposed by consumer groups, according to Consumers Union, the policy and advocacy division of Consumer Reports.
The House is expected to vote on the revised bill on Wednesday, June 20, and the Senate will take up the legislation next week.
“This bill includes some important reforms that will improve the FDA’s ability to monitor medical devices on the market and to notify patients and require stricter testing when safety problems arise,” said Lisa McGiffert, director of Consumers union’s Safe Patient Project (www.SafePatientProject.org). “But there is clearly more work that needs to be done to ensure that the FDA has all the tools it needs to ensure medical devices are safe and effective before they can be used on patients.”
Consumers Union had urged lawmakers to adopt a number of critical patient safety reforms to improve medical device oversight. Unfortunately, the politically powerful medical device industry succeeded in blocking these needed protections from being included in both the House and Senate bills.
Nonetheless, some key patient safety provisions were included in the final bill, including:
Making it Easier for the FDA to Re-Classify Problem Devices: The revised bill includes a provision from the Senate-passed version of the legislation that makes it easier for the FDA to re-classify medical devices. Consumers Union and other patient safety organizations supported this provision because it will enable the FDA to more easily up-classify devices that have caused serious harm to patients so that similar device applications in the future will require more scrutiny of their safety.
Setting a Deadline for Implementing a UDI System: The revised legislation merges provisions from the House and Senate bills to require the FDA to issue regulations within six months to establish a Unique Device Identification (UDI) system for high risk, life sustaining and implantable devices and to implement it within two years of finalizing the regulations. The FDA does not currently have the tools and resources to adequately track and evaluate how patients with implants and other high-risk devices are faring. Effective post-market surveillance is dependent on having UDI in place – that includes effective use of the Sentinel Initiative, device registries, and the ability to more precisely identify problems and inform patients when problems with devices are identified.
Requiring Timely Post-Market Safety Studies: The revised bill includes a provision from the Senate-passed version that requires post-market 522 studies to begin no later than 15 months after being ordered. These 522 studies are ordered by the FDA to address concerns about the safety of devices, typically based on reports to the agency about patient harm. Until these ordered studies are completed, doctors continue implanting them in patients and future users of the devices are endangered.
Putting a Hold on Risky Clinical Studies: The revised bill includes a provision from the Senate passed version of the legislation that gives the FDA the authority to put a hold on studies that pose unreasonable risks to their subjects. This allows a time out for re-evaluation and then allows the research sponsors to make adjustments or provide more information to address concerns and resume the study.
The revised FDA User Fee bill includes some provisions that were opposed by Consumers Union, including:
Tying FDA’s Hands to Disapprove Bad Clinical Trials: The revised bill adopts a provision from the House-passed version of the legislation that will limit the FDA’s ability to reject applications for an Investigational Device Exemption. The FDA has a specific responsibility to ensure that the clinical studies done to investigate new devices are worth the risk to the subjects involved and to ensure that the many more people who would be exposed to a device post clearance or approval are not put at risk.
If the FDA believes that a device ultimately will not be approved, it currently has the authority to reject an application for an investigational device exemption, which provides manufacturers a limited approval pathway for use of the device in the investigational stage. The revised FDA User Fee bill retains the House provision that does away with this authority.
Weakening Current Conflict of Interest Protections: The revised bill adopts provisions from the House and Senate-passed versions of the legislation that weaken 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.
Contact: Michael McCauley, email@example.com, 415-902-9537 (cell)