Many Americans trust that prescription drugs have been approved by the Food & Drug Administration and are safe and effective for patients to take. After all, the U.S. health care industry is highly regulated, the FDA exists to police unsafe products, and multiple state and federal laws, starting with the Food, Drug & Cosmetic Act, require drugs to be approved before sale. The last thing you think, when you pick up your prescription, is that the pill you or your family might be about to taken isn’t actually approved for sale.
But the truth is that hundreds or thousands of unapproved drugs are on the market. Unapproved drugs are deemed adulterated and misbranded, and shipping or selling them in the market is illegal. The Block Firm’s recent analysis of an FDA database found that almost 3% of prescription drugs known to be for sale in the U.S. are unapproved—more than 1,400 of them, many for serious conditions like thyroid disease, seizure disorders, and for use during pregnancy. To take one example, at least six different companies are selling unapproved epinephrine, which is used in life-or-death emergencies.
By skipping the drug approval process—that is, by skipping the development of proof that their drugs are safe, effective, and properly manufactured—drug companies can race to market at a lower cost, leading to higher profits. That exposes patients to dangerous drugs and more honest firms to unfair competition. And if drug companies are not willing to be transparent with the FDA and prove that their drugs are safe and effective, what other corners are they cutting?
In theory, drugmakers who violate laws against adulteration and misbranding face heavy fines and even jail time for executives. But in practice, very few drugmakers are even punished and caught because the FDA lacks the resources to police every corner of the market. Unscrupulous drugmakers exploit loopholes and the FDA’s limited resources to hide in plain sight, knowing they are unlikely to be caught.
Some drugmakers will claim that their medicines are not “really” drugs, just “supplements,” which are less regulated. But that is dishonest: products marketed to treat diseases or conditions are drugs under the law, and companies that sell them must register them and seek approval before selling them. Other drugmakers will claim that their drugs are “grandfathered” in to the FDA regulatory system and do not need to actually prove the drugs are safe and effective. But the FDA has repeatedly found that essentially no drugs on the market today are grandfathered in as safe.
That is why private enforcement of drug safety laws is so important. The Block Firm recently exposed a massive scheme to sell adulterated thyroid drugs, which the FDA didn’t approve and wouldn’t have approved due to defects in the manufacturing and design process. Our work recovered nearly $50 million for patients nationwide. Read more about the thyroid class action here.
If you have been hurt or cheated by unapproved or unsafe drugs, contact the experts at The Block Firm. With decades of expertise, including experience inside the pharmaceutical industry, we know how to stand up when drugmakers put profits ahead of patient safety.
