The FDA has a plan to close a loophole exposed by Martin Shkreli
For the FDA, that means closing a gap that let Shkreli's Turing Pharmaceuticals raise the price of a 62-year-old drug by 5,000%.
The document, first spotted by Bloomberg, details a way to speed up the review process for certain generic drug applications. Specifically, it'll apply when they're substituting for drugs that no longer fall under patent protection and - here's the key - are made by only one company.
Bloomberg reports this change could speed up the process for as many as 125 drugs.
Had it been in place last year, a generic rival for Turing's Daraprim, a drug that fights toxoplasmosis infections and is particularly needed in people with weakened immune systems, might've been quick to appear. Turing acquired the drug and became its only manufacturer in the US - giving the company the leverage to raise the list price from $13.50 a pill to $750.
A Congressional hearing on pharmaceutical drug price increases called in FDA director Janet Woodcock to discuss what the regulatory agency can do to stop this kind of price increase from happening. Before this update, the FDA did have certain fail-safe measures in place, like when drugs are facing a shortage. The new language adds the urgency of drugs made by only one company (that is, not made under any other dosage level or formulation by another company) that still face no competition.