November 14, 2012
The FDA law is supposed to make sure that all medical products sold in the U.S. are safe and effective. Unfortunately, it doesn’t.
There are several giant loopholes in the law, including loopholes for compounding pharmacies, as well as companies that call themselves compounding pharmacies but aren’t. That loophole is enormous, and that’s why hundreds of people are now sick with fungal meningitis and so many have died.
And that’s just the tip of the iceberg, because thousands of people got medications that are not proven safe and not proven effective. And I’m not just talking about the injections that harmed Jerry, which we heard about today. There have been many other examples of unsafe medical drugs sold through compounding pharmacies, including cancer drugs that were either weaker or stronger than they should have been.
There’s enough blame to go around, but I don’t want to play the blame game today. Obviously, a major part of the blame is on the compounding pharmacies that didn’t care enough about patients to make sure the products they were making were safe. This includes the specific pharmacies in Massachusetts that have been identified, but also includes many other compounding pharmacies. We also have to wonder about the state and FDA inspectors and officials who knew that there were serious, life-threatening problems but didn’t do enough to fix them, and the doctors who ordered products from compounding pharmacies without considering safety issues.
The innocent victims are the patients who trusted their doctors and the FDA to make sure their medications are safe. The costs to them are enormous, but the human costs and the financial costs.
This VALID Compounding Act is designed to close the loopholes that are so harmful to patients. It is a well thought out, comprehensive, and balanced bill, and I congratulate Rep. Markey and his staff on the bill and on their excellent report.
The FDA will do a much better job of enforcement if the law is improved. The FDA’s hands have been tied — they haven’t been able to get the information they needed to fully investigate. FDA’s resources are very limited, so the agency tends to focus on the slam dunks, not the efforts that are less likely to be successful.
This law will save lives. It will save a lot of lives if it isn’t watered down by those who care more about protecting companies than protecting people. We heard a lot of opposition to safety regulations this past year in the House of Representatives, based on claims that safety regulations kill jobs. Let’s remember that having more inspectors and requiring research evidence of safety will create jobs. Personally, I’d rather make new jobs for inspectors and researchers, than jobs for people making unsafe medical products. This law will make new jobs and it will save lives and healthcare dollars, a great combination.
In closing, I want to point out that the history of the FDA is a history of disasters followed by improvements in the law. The Food, Drug, and Cosmetic Act passed in 1938 after 107 people died, mostly women and children, from taking an elixir made with an antifreeze that was added to improve the color. That law was greatly strengthened in 1962, after the Thalidomide tragedy caused thousands of babies to be born without terribly deformed arms, legs, fingers, and toes, and in some cases no arms or legs. And, medical devices – even implanted ones – were not regulated until 1976, after many women died or became infertile from the Dalkon Shield IUD.
This is the latest tragedy, and it is an important opportunity to prevent similar tragedies in the future. That’s why it is essential to act now. It is not a partisan issue, and we look forward to working with Congress to act quickly.