The FDA Isn’t All That Disturbing

Note: This post comes from one of our favorite readers (he has requested to remain anonymous), who has also contributed posts in the past about FDA issues. While not directly hair loss related, I wanted to post it to give critics of the FDA a little background on why the agency is important:

It is likely that few BaldingBlog readers have worked at or significantly interacted with the FDA. As such, many of the comments related to the FDA contain appropriate concerns with this underresourced agency and – more often – criticisms that reflect poor understanding of both drug development and the approval process. Ironically, at any given time, different articles from thoughtful sources have simultaneously argued that the FDA is too lax and too strict related to approval of drugs.

An article on this blog recently appeared directing readers to many disturbing features of this agency (Article Points Out How the FDA is Disturbing). I’d like to take readers with me on a walk down “memory lane”.

Up until the last few centuries, few federal laws regulated the contents and sale of food and pharmaceuticals produced in the US. In the 1800s, counterfeit, contaminated, diluted, and decomposed drug materials were common, which resulted in the establishment of the Import Drugs Act in 1848 to enforce purity of drugs. However manufacturing and marketing of drugs was still “a circus”: milk was unpasteurized, cows were not tested for tuberculosis, and there were no restrictions on opium, morphine, heroin, or cocaine labeling or marketing.

In 1906, The Pure Food and Drug Act required that certain specified drugs, including alcohol, cocaine, heroin, morphine, and cannabis, be accurately labeled with contents and dosage. Previously many drugs had been sold with secret ingredients or misleading labels. This Act also prohibited interstate commerce of misbranded and adulterated drugs, but did not address drug standards, false advertising or drug facility inspection. Also, existing laws did not require that any clinical studies be performed to demonstrate that a drug was safe.

The FDA was created in the early 1930’s. In 1938, the Federal Food, Drug, and Cosmetic Act passed mainly in response to the death of more than 100 patients – mostly children treated for streptococcal infections – due to a sulfanilamide medication that contained diethylene glycol (antifreeze) as a solvent make a liquid form. This Act required new drugs to be safe before marketing.

In 1962, the FDA required drug manufacturers to prove drug effectiveness and safety before marketing. A major impetus for this requirement was the recognition that thalidomide – a drug used for both sedation and morning sickness in pregnant women – produced severe birth defects. The major process for evaluating the safety and efficacy has remained (with some exceptions) the randomized, placebo-controlled, parallel-group study comparing a drug to a control.

In the mid- and late 1980s, many HIV activist organizations worked with the FDA to create new rules to expedite approval of drugs for life threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment options (commonly called “compassionate use”). This was a major shift in regulatory mindset that lessened the proof required for drug approval (and increased risks) due to the need to accelerate the process of getting drugs to those with life-threatening illnesses and few options.

In summary, since 1938 the FDA has evaluated drug applications in the US with a focus on determining the risk-benefit balance. The FDA – with its bureaucracy and challenges – is an agency that makes their evaluations fairly transparent. My own view is that FDA approval does not represent a lifetime guarantee of safety and efficacy, and that physicians should educate about known risks and benefits and that consumers/patients should be capable of (and willing to spend the time) examining known and publicly available data to make informed judgments.