Is Unfair Exploitation of a Legal Loophole Blocking Access to Generic Drugs?

Under federal law, after a brand-name drug's patent expires (or if the patent is invalid), a generic drug manufacturer can make a copies and sell them if they are bioequivalent to the brand-name drug. The generic manufacturer must have a sample of the brand-name product so that it can make copies. If the copies are good copies, the FDA approves them, they are marketed to the public, and drug prices drop, to the public's benefit. (This oversimplifies the process, but that's basically what happens.)

But as explained in today's Washington Post,this process doesn't work for all brand-name drugs:

Some drugmakers assert they are unable to create cheaper generic versions of drugs because their rivals are exploiting a legal loophole. ... [T]he government has placed restrictions on distributing some drugs that are dangerous or prone to abuse. Critics say manufacturers of those brand-name drugs are using the restrictions to stop generic makers from getting samples to test. No samples, no generics. ... Critics warn that the practice is bound to become more entrenched and widespread.

The Federal Trade Commission is investigating to determine whether withholding samples is an unfair method of competition. The Connecticut Attorney General is investigating as well.

Comments

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