In 1996, the FDA approved 53 drugs. In 2009, less than half that number entered the market, according to an Atlantic Monthly article by Megan McArdle, which investigates why fewer and fewer drugs are in stores.
The fact is, no single pipeline theory works well on its own; they all interact. A stodgier FDA can mean stuffier decisions inside companies. Smaller pipelines make for bigger mergers. Bigger companies, in turn, may mean smaller pipelines.
Both conservatives and the drug companies themselves blame stringent FDA regulations that require increasingly expensive clinical trials, while liberals argue drug companies are too focused on developing medications for common illnesses, where they can make higher profits, rather than for less common diseases. To a certain degree, McArdle writes, both arguments fall short of fully explaining the reason behind the big drop in the number of drugs on the market.
The FDA isn’t rejecting drugs at a higher rate than it has in the past. And companies are spending 11 times what they did in 1980 on drug research and development, though the drugs often fail in the final stages of clinical trials. Still, it seems neither the FDA nor companies are completely risk-averse. But it is possible, the article posits, that drugs are simply harder to develop nowadays, since researchers have already taken care of well-understood diseases, and are now tackling tougher illnesses, like cancer or obesity.
In many ways, the task facing researchers is simply more difficult than it was 20 or 30 years ago. Back then, chemists had big fat targets like angiotensin, a protein that causes blood vessels to constrict. Scientists knew it caused high blood pressure, and better yet, they were pretty sure they could develop a small molecule (that is, one that can easily enter the bloodstream) that would hit what they were aiming at. Best of all, hypertension provided an enormous market. Driven by similar finds in other areas, an age of blockbusters dawned: the Lipitors and Prilosecs and Allegras.
These days the targets seem smaller, fewer, and farther away. The best-understood diseases already have a lot of good drugs treating them. New treatments need to prove that they have better efficacy, fewer side effects, or something like a longer-lasting dose that makes them superior to the pills already on the market.
