FDA Modernization Act 2.0 Is A Welcome Reprieve For Puppies, But More Comprehensive Reform is Urgently Needed

See By Jeffrey A. Singer of Cato.

"Today the U.S. Senate passed, by unanimous consent, the FDA Modernization Act 2.0, co‐​sponsored by Senators Rand Paul (R‑KY) and Cory Booker (D‑NJ). The bill removes the mandate, included in the 1938 Food, Drug, and Cosmetic Act (FDCA), that requires all drugs to be tested on animals to exclude toxicity. The bill does not end animal testing, but it now permits drug developers to use alternative methods to test for toxicity when feasible. Similar provisions are in a bill passed earlier in the U.S. House of Representatives, making this reform likely to become law.

Since the FDCA was passed 83 years ago, research has shown animal testing to be an inconsistent indicator of drug toxicity and, in many cases, alternative methods are equally or more reliable. Yet, because of the 1938 mandate, hundreds of animals must be killed for a pharmaceutical company to bring a single drug to market. Last year, Senator Paul held a “Puppy Press Conference,” making the case for the reform.

This bipartisan legislation is certainly commendable. But, to be fair, it’s low‐​hanging fruit. The FDCA needs much more comprehensive reform and must be made consistent with its authors’ pledge to respect the people’s right to self‐​medicate.

In our white paper “Drug Reformation,” Michael Cannon and I provide a laundry list of reform proposals, ranging from ending the FDA’s monopoly over deciding which drugs may be over‐​the‐​counter and which may be prescription‐​only, to allowing Americans to purchase drugs that have been approved by designated certification agencies, including foreign regulatory bodies. We point out:

According to one study, recognizing drug approvals by regulatory bodies in Canada and Europe between 2000 and 2010 would have given U.S. consumers quicker access to 37 “novel” drugs for which “no other FDA‐​approved prescription medicine had the same mechanism of action,” including 10 drugs treating mostly orphan diseases “for which no alternative therapy was available in the USA.” Such recognition would have allowed U.S. consumers to access those drugs a median of 13.6 months earlier.

We also suggest creating intermediate drug classifications, such as “behind the counter,” which would still require consumers to get permission from government‐​approved gatekeepers (pharmacists), but would let them avoid the costs of a visit to the doctor to get a prescription.

The FDA Modernization Act 2.0 is a timely demonstration of bipartisan FDA reform and a welcome reprieve for the puppies. Hopefully, in the not‐​too‐​distant future, we can look back on its passage as the first in a long line of pharmaceutical regulatory reforms."