'Father' of generic drug law applauds Supreme Court pay-to-delay decision

Congressman Henry Waxman, one of the fathers of the 1984 law that greatly increased the use of generic drugs in the United States, applauded Monday's Supreme Court decision that shook the pharmaceutical industry.

The Supreme Court upended a big part of the relationship between generic and brand-name drug companies on Monday by siding with the Federal Trade Commission in FTC v. Actavis, et. al., in the so-called pay-to-delay case. Basically, the court said that if brand-name companies pay generic competitors to delay trying to introduce cheaper generic versions of drugs, such arrangements can be subject to antitrust laws.

The Supreme Court decided 5-3 on the decision, with Justice Stephen Breyer writing the opinion for the majority, which included Anthony Kennedy, Elena Kagan, Sonia Sotomayor and Ruth Bader Ginsburg. The dissent was written by Chief Justice John Roberts, who was joined by Justices Antonin Scalia and Clarence Thomas. Justice Samuel Alito recused himself from the case.

A link to the opinions is here.

Waxman (D.-Calif.) joined Utah Sen. Orrin Hatch (R) as the main proponents of the Drug Price Competition and Patent Term Restoration Act of 1984, which has come to be known by many in the drug industry as the Hatch-Waxman Act.

Waxman wanted more competition, not less, which he said is the result of the pay-to-delay or "reverse payment" deals.

"The Court echoed what I, along with many other members of Congress, have repeatedly said: the over-arching goal of Waxman-Hatch is to foster competition in the pharmaceutical industry," Waxman said. "The type of collusive agreement at issue in this case represents a total perversion of the spirit of this law. This is a significant victory for consumers. But I will continue to vigilantly watch to ensure that Waxman-Hatch patent settlements are pro-competitive and pro-consumer in the future.”