Attempts to regulate and ensure the safety of medications in the United States date back to the early years of the 19th Century. Those attempts were largely unsuccessful. It took another 86 years before Congress passed an effective law addressing the issue of food and drug safety.
That law, signed by President Theodore Roosevelt in 1906, led to the establishment of the Food and Drug Administration, a federal agency tasked with protecting the public from dangerous medications. Today, in addition to regulating prescription and over-the-counter medications, the FDA is responsible for insuring the safety and purity of food (for animals as well as humans), veterinary products, cosmetics, medical devices, dietary supplements, and more.
The Early Decades
The first attempt to regulate drug safety in the U.S. came in the wake of Dr. Edward Jenner's discovery of the smallpox vaccine in 1796. As smallpox was still a common, dreaded, and often fatal sickness at the time. It was not long before hucksters and charlatans began exploiting demand for the treatment by selling fraudulent, ineffective, and sometimes dangerous versions of the vaccine.
In 1813, Congress passed the Vaccine Act, which charged federal agents with ensuring the purity of the smallpox vaccine and distributing it to the people. Seven years later, a smallpox outbreak in North Carolina due to a tainted supply of vaccine led to the repeal of the law.
In 1820, a group of concerned physicians founded the United States Pharmacopeia, a non-profit organization still in operation. Their objective was to get legislation passed at the federal level that would hold drug manufacturers accountable for the purity and efficacy of their products.
Those attempts were largely unsuccessful, and it was not until the 1880s that the federal government once more stepped up to the task of protecting the public from tainted medications and food products. In 1883, scientist and social activist Harvey Wiley was appointed chief chemist at the USDA's Division of Chemistry, where he led an investigation, culminating in an extensive, ten-part report called Foods and Food Adulterants.
Around the turn of the 20th Century, Wiley and his division allied themselves with other activist groups, including medical associations, for the purpose of lobbying federal lawmakers to create legislation that would set national standards for food and medication. These efforts came at the same type that “muckraking” journalists were publishing exposés on food processing companies and pharmaceutical manufacturers that were selling tainted products.
Eventually, Wiley's work led to the passage of the Food and Drug Act of 1906 under the Administration President Theodore Roosevelt. It marked the first time the federal government had genuine authority to regulate the sale and transport of pharmaceuticals and commercial food products. Inspections were to be carried out by Wiley's division at the USDA.
Unfortunately, the law was gutted in 1911 by the Supreme Court, which ruled that the law did not apply to false claims over efficacy. Although the law was amended the following year, defining pharmaceutical misbranding as “false and fraudulent [claims] of curative or therapeutic effects,” the courts continued to set a high standard of proof for such claims – and restricted the Division of Chemistry's power to enforce the law.
In 1927, the USDA Division of Chemistry became the Food, Drug and Insecticide Bureau, which was renamed the Food and Drug Administration in 1930. During the decade that followed, investigative journalists continued to expose dangerous products that had slipped through the cracks of the 1906 law, including a cosmetic known as “Lash Lure,” which caused many women to go blind.
Events came to a head in 1937, when the antibiotic sulfa drug manufactured and sold by the S.E. Massengill Company (a predecessor of GlaxoSmith Kline) killed 100 people. The drug contained an untested solvent known as diethylene glycol (a substance used in brake fluid, antifreeze, and automotive lubricants). As a result of this tragedy, Congress passed the Food, Drug and Cosmetic Act of 1938, which greatly expanded the regulatory powers of the FDA, requiring pre-market review of all new pharmaceutical products and banning false claims of efficacy without requiring proof of intent.
Exercising Greater Authority
Over the next decade, the FDA began designating certain medications as “prescription-only,” a category that was written into law by the early 1950s. Over the next several years, the FDA gained additional powers as the courts closed loopholes that allowed drug companies to sidestep the “false therapeutic claims” provision of the law. Among these expanded powers was the authority of the FDA to recall ineffective and dangerous medications. By the 1960s, the FDA was empowered to require clinical reviews (including those already on the market), restrict drug advertising to formally approved uses, and conduct inspections of drug company operations.
One of the unintended consequences of the FDA's expanded authority was a significant increase in the amount of time it took to approve new medications. By the mid-1970s, over 90% of new medications that the FDA deemed vital for approval were available overseas before they were available in the U.S.
Another problem was that the amount of time necessary to conduct clinical trials mandated under the law shortened a drug manufacturer's period of exclusivity under existing patent laws. The 1984 Hatch-Waxman Act was an attempt to keep drug pricing reasonable by allowing generic manufacturers to conduct their own clinical trials while a name brand drug was still under patent, and at the same time allowing major drug companies to keep its patent protection for an extended period – thereby encouraging the development of new medications.
The FDA Today
Additional attempts to streamline the FDA approval process over the past several years include new rules, issued during the 1980s during the AIDS epidemic, that expedited the approval of medications for the treatment of life-threatening illnesses and allowing patients with limited options to obtain experimental medications that had not yet received formal approval.
Drug companies and medical device manufacturers also began to employ Section 510(k) of the Food Drug and Cosmetic Act, which allows them to bypass normal testing requirements if they can demonstrate that a new product is “substantially equivalent” to one that has already been approved. Most recently, the 21st Century Cures Act has allowed such companies to submit “data summaries” and “real world evidence” in lieu of formal clinical studies.
While having good intentions, the 510(k) Pre-Approval process has resulted in a number of harmful products being brought to market. It remains to be seen if the 21st Century Cures Act will have similar results.