Companies may make the generic drugs themselves or permit another manufacturer to do it, said Mark Lemley, a law professor at the Stanford Law School in California.
Other companies may allow generics from other manufacturers to come to the market — eventually — but only after filing citizen petitions to the Food and Drug Administration to delay their approval, Lemley said.
A citizen petition can be filed if an individual or an entity has concerns about the safety of a certain drug.
The FDA will delay approval of the drug until the investigation is complete, which can take months, Lemley said. The companies could continue to delay the drug through petitions up until they are at risk of drug pricing negotiation, he said, with the benefit being extra time to earn as much revenue as possible.Read More