Last week the president of the United States met with a group of CEOs from pharmaceutical companies and promised to drastically cut regulations instated by the Food and Drug Administration (the FDA) by 75-80%. The president has also issued an executive order, applicable across all federal agencies, stating that for every new regulation issued, at least two existing regulations must be eliminated. and in particular effectiveness.
It is reasonable to expect a government agency that has been in place since 1904 could benefit from some rescaling, but what would an 80% cut to the FDA’s regulations and policies look like? Part of that answer will depend, of course, on who is appointed to head the FDA. But to get a better idea of what could be cut, let’s look at what the FDA actually does.
What does the FDA do for you?
1. The FDA ensures that the food you eat is “safe, wholesome, sanitary, and properly labeled”. (Exceptions include meat, poultry, and some egg products which are instead regulated by the US Department of Agriculture.) This includes, for example, routine, random testing of produce and cheeses that have protected consumers by detecting contamination from ecoli bacteria and listeria.
The Food Safety Modernization Act, signed into law by President Obama in 2011, further extends regulations to prevent contamination from happening in the first place, including rules on sanitary transportation, verification programs for foreign suppliers, and mitigation strategies to protect our food against intentional adulteration that could cause harm to public health.
2. The FDA ensures that cosmetics and dietary supplements are safe and properly labeled. Cosmetics do not have to be approved by the FDA before they are marketed, but the FDA does regulate their safety and labeling. Thus, a cosmetic company doesn’t have to prove that its face cream will actually make you look younger, but it does have to be safe to apply to your skin and come in a packaging that accurately describes its ingredients.
For example, did you know that lead is found in most cosmetics, from eye shadow to lipstick? While the FDA cannot regulate a maximum amount of lead in the products some of us apply daily, FDA researchers do track how much lead is contained in different products, making this information available to the public and offering suggested limits.
The FDA has further called out certain dietary supplements for including controversial stimulants that act similarly to amphetamine but labeling them as dietary ingredients instead.
Keep reading to find out what else the FDA does for you ...
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 Everyday Einstein’s Quick and Dirty Tips for helping you make sense of science. You can become a fan of Everyday Einstein 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 everydayeinstein@quickanddirtytips.com.
Image courtesy of shutterstock
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