It’s called the DESI project. DESI stands for the Drug Efficacy Study Implementation. It was implemented as part of the rushed and poorly worded Kefauver Harris Amendment to the 1962 Federal, Food, Drug, and Cosmetic Act. That amendment required (in part) that every new drug for which someone received a patent between 1938 and 1962 needed to be re-tested to be sure that it was not only safe but effective. Effective, in this case, means only that the benefits outweigh the risks of taking the drug no matter how slightly. But not all drugs got a patent between 1938 and 1962. The gout medicine, for example, has been used for much of human history. And without a patent at that. It, and about 2% of all prescriptions in America, were grandfathered in and were now illegal.
The FDA did not want to create a shortage of these old drugs because of a poorly worded law. So it said that until a manufacturer submitted a patent application which the FDA reviewed and approved, we could continue to buy these old drugs at their familiar, low prices. But the minute a patent application is approved, all other versions of the drug have to be removed because this old medicine is now “new” and its “sponsor” (who did not invent a thing) gets to enjoy five to 20 years of monopoly. In other words, the drug company that has the lawyers at the ready to submit the right paperwork on a drug that’s been around for decades or even thousands of years can make a lot of money.
The FDA started implementing this ill-thought through amendment in 2006. Well-paid lawyers now keep track of the next old/new drugs whose prices are about to go through the roof. You might be interested to know (for example) that estrogen (the Pill) is on the list. If you are a woman of child-bearing age, you may have to pay through the nose not to have kids. Because of DESI.
We can do something about this. These drugs are so old and have been in use for so long that FDA could monitor real world evidence of their effectiveness and approve their sale as generics on that basis. But only if Congress passes a law letting them do so.
Congress seems to be interested in bringing down drug prices. Why not begin by altering the Kefauver Harris Amendment of 1962? According to Peter Hutt, the DESI project will hike the prices on 12,000 to 16,000 drugs. And what are these drugs?
Peter Hutt relays part of an FDA testimony from 1960: “The drugs cleared through the new drug procedures since 1938 constitute the most important medical advances in history. Among these drugs are all of the sulfa drugs except sulfanilamide which was exempted by the grandfather clause of the 1938 Act, many of the antibiotic drugs, the steroids, including sex hormones and anti-inflammatory agents, corticotropin, all of the antihistamines, tranquilizers, antimotion sickness pills, diuretics, hypotensive agents, anticoagulants, antidiabetic drugs and many” others.
All of these are about to get very, very expensive unless Congress acts.