March 9, 2007
The safety of medical products, especially prescription drugs and medical devices, has become an urgent issue for Congress. Legislative solutions will not be easy, but they have never been more important. A quick solution is not as important as an effective solution. Several policy proposals that are being seriously considered are likely to do little good, and some seem likely to do more harm than good.
Patient and consumer groups have been meeting with Congressional staff for over a year on drug safety legislation. There is a diversity of opinions among those groups. The drug safety proposals that seem most likely to pass have considerable support from industry, varying degrees of support and opposition from patient groups that receive financial support from industry, and little support from consumer groups that are independent of industry funding.
There is even more concern about PDUFA and MDUFMA, both of which are focused primarily on the goal of quick approval, but not on the equally important goals of preserving and improving the public health.
The National Research Center for Women & Families is a non-profit organization dedicated to improving the health and safety of all Americans. We are very concerned about the lack of adequate funding at the FDA, but even more concerned about the weakened clout of those who are dedicated to science and to safeguards. When ideological or industry pressures undermine science, FDA scientists, and FDA safeguards, the public is harmed. That has happened, and we need to reverse that trend.
These are agency-wide problems, but we believe that the problems are most urgent at the Center for Devices and Radiological Health (CDRH). Some medical devices are reviewed under a process that is similar to, albeit with weaker standards than, the process for prescription drugs. Most medical devices are approved under a much faster, easier process called the 510k process. Under the 510k process, many medical devices are approved without even undergoing clinical trials if they are considered “substantially equivalent” to another product on the market. Unfortunately, the definition of “substantial equivalence is very loose. Many of the products approved this way are actually substantially different from anything already on the market.
Do you remember when Bausch & Lomb contact lens solution, ReNu with MoistureLoc, was removed from the market last year, after consumers were blinded by eye infections? That product was approved under the 510k process, and no clinical trials were conducted. Perhaps the contact lens solution seemed similar to other contact lens solutions, but the product was “improved” in a way that made dangerous eye infections much more likely.
You’d think that the FDA would respond to these and other medical device problems by being more cautious. You’d be wrong. Instead, FDA is making the approval process for devices even easier. In January, the FDA held a public meeting on a new device called NeuroStar, which is intended to treat depression using magnetic pulses to the brain. For that product, clinical trials were conducted and the results indicated no significant difference whether the product was turned on or turned off. Even so, the FDA is considering approving the product under a 510k, because the product seems to be less dangerous than electroshock therapy, which is a completely different product. Apparently, as long as it is less dangerous, the FDA no longer cares if it is substantially equivalent or even similar — or effective.
Several of the major problems facing the approval process at the FDA include:
- Lack of resources for adequate safety reviews
- Pressure to review quickly
- Approval of products that will require post-market studies to prove whether they are safe or effective
- Lack of inspections of facilities
- Direct to consumer advertising designed to sell rather than educate, and which does not adequately warn consumers about risks
- Complete break-down of the adverse reaction reporting system and other post-market surveillance mechanisms
These are all problems for drugs and devices. And they need to be fixed if the FDA is to fulfill its mandate to protect the public.