Do you know what the Food and Drug Administration does?
3. The FDA regulates tobacco products. In 2009, Congress enacted the bipartisan Family Smoking Prevention and Tobacco Control Act that allows the FDA to protect future generations from the health dangers of tobacco. Under this rule, the FDA restricts the sale of tobacco products to minors, does not allow tobacco companies to pass out free samples, and places requirements on packaging, like the inclusion of health warnings, ingredient lists, and restrictions on the use of language like “mild” or “light”.
4. The FDA ensures that your (and your pets’!) drugs, your vaccines, and your medical devices are both safe and effective. The FDA’s Center for Drug Evaluation and Research evaluates all new drugs for safety before they reach the market where we can buy them. The FDA also regulates drug labeling including monitoring any new side effects of approved drugs that may need to be added to the label and preventing drug companies from misrepresenting what their product can do on its labels.
However, one of the areas the current US administration has suggested might see the largest cuts is in the requirement that drugs be proven effective before given FDA approval. In fact, one of the finalists for the position to head the FDA has stated clearly that, when it comes to drugs, the FDA should “let people start using them, at their own risk.”
The FDA didn’t always regulate drug effectiveness. In the early 1960s, a large number of cases from across the world of babies born with severe birth defects, including the shortening or absence of limbs, were traced to the drug thalidomide. Thalidomide was marketed as a sleeping pill and was extremely popular: the demand for it in European markets was as high as the demand for aspirin.
Soon the drug was also touted as a remedy for morning sickness and began being readily prescribed for this “off-label” use, starting in Australia. However, despite heavy pressure and approval of the drug in 46 other countries, FDA inspector at the time Frances Kelsey prevented approval of the drug in the US, citing incomplete and insufficient data on its safety and effectiveness as a morning sickness cure.
Once the drug was linked to birth defects, Kelsey was lauded a hero and her protective efforts inspired the Kefauver-Harris Drug Amendments Act in 1962 which tightened restrictions around the drug approval process, including the requirement that a drug actually be proven effective. Thalidomide is now FDA-approved, not as a remedy for morning sickness but for the treatment of symptoms related to leprosy and multiple myeloma.
5. The FDA advances public health by supporting research investigating new drug and product innovations and by approving new drugs. Many frustrations with the FDA are related to the length of time (and amount of money) that it can take to get a drug approved and on the market. Terminally ill patients, for example, may not want to risk waiting for the FDA stamp of approval that comes with fully vetted drugs.
However, it is not clear that the length of time it takes for an effective drug to make it into the hands of the patient is a result of the FDA’s approval process rather than a limit on our ability to find drugs that work. Although it can take a decade to develop a drug from start to finish, the actual FDA approval process takes less than a year and, as has been noted by several former commissioners and assistant commissioners, is the fastest in the world. The FDA also offers programs to help prepare pharmaceutical companies for the specifics of the approval process.
The clinical failure rate for new drugs is around 90% but that is usually because those drugs don’t do the job they are designed to do. If drug regulations go the way of cosmetics, we’ll have many more options, but with no guarantee those options actually do anything for us. Insurance companies may also be hesitant to pay for remedies without sufficient evidence of their utility.
Requiring that drugs actually be effective means that we demand more of our drug companies and also justifies the price they set for their product. Regulation doesn’t have to hinder scientific innovation and can instead inspire us to do better.
Until next time, this is Sabrina Stierwalt with Ask Science’s Quick and Dirty Tips for helping you make sense of science. You can become a fan of Ask Science on Facebook or follow me on Twitter, where I’m @QDTeinstein. If you have a question that you’d like to see on a future episode, send me an email at email@example.com.