How safe are the drugs you’re taking?

You might think that the FDA ensures that the drugs you’re taking are safe. And, generally, drug companies must complete several costly drug testing phases before the FDA approves a drug to go to market. But, did you know that doctors in the U.S. prescribed unsafe drugs more than one hundred million times before they were recalled? How safe are the drugs you’re taking?

We explained in an earlier Just Care post that once popular drugs may be pulled from the market. Sometimes, it’s because the clinical trials that appeared to show a drug was safe and effective were too small to accurately reflect the drug’s safety. Sometimes, it’s because healthy younger people test the drug and older and/or less healthy people react differently to it, or people use the drug differently in the real world than as tested in the trial, where the environment is controlled. Or, sometimes, it’s because drugs are prescribed off-label and have unforeseen effects.

The FDA also sometimes streamlines its drug approval process, much like its medical device approval process, to help drugs get to market faster. But, in the process, it may approve drugs that are unsafe or ineffective.  Indeed, a recent article in JAMA found that the majority of cancer drugs the FDA has recently approved don’t work.

It can be several years before FDA-approved drugs are pulled from the market. According to a June 2016 article in the International Journal of Health Services by Steffie Woolhandler, David Himmelstein, David Bor and Danny McCormick, 17 drugs that the FDA had approved were subsequently withdrawn over a period of 18 years. While they were on the market, doctors prescribed them 112 million times.

Given the risks to patient safety of the current approval process, Congress should be requiring the FDA to raise the bar for approving drugs. Instead, the House has already voted on legislation, the 21st Century Cures Act, that would speed up the FDA approval of drugs, relaxing the process so that it is less stringent. And, the Senate is now considering companion legislation.

Recently, six former FDA commissioners argued that the FDA should become an independent agency, like the SEC, Securities and Exchange Commission. It has oversight of products that represent about 25 percent of the U.S. economy. A federal budget process that is unpredictable makes it difficult for the FDA to function effectively; the FDA is currently too often a tool of the politicians, many of whom are beholden to the pharmaceutical and medical device companies. To ensure patient safety, the FDA should be an independent agency, not an arm of the Department of Health and Human Services.

Here’s more from Just Care:

• Bitter pills: Once popular drugs pulled from the market
• Side effects of drugs prescribed off-label often serious
• Six tips for keeping your drug costs down if you have Medicare
• Majority of cancer drugs recently approved by the FDA don’t work
• Are your drugs delivering good value?