While we were away, the pharmaceutical industry was involved in two big court decisions, each of which could transform the industry and change how, when, from whom and for what cost Americans get medicine. There was even a slice of the First Amendment in the mix.
One case will be heard by the Supreme Court in this session and the other might be headed there.
As some of you might have read, including in Saturday's Inquirer, the Supreme Court said it would hear arguments in Federal Trade Commission v. Watson Pharmaceuticals, et al., which questions the practice of brand-name companies striking deals with generic companies, which end up delaying potential introduction of cheaper medicine in exchange for dropping suits challenging the viability of patents. These are the so-called pay-to-delay agreements.
Drugmakers say that patent litigation outcomes are uncertain, meaning no one can be sure when a cheaper generic might reach the market, and they are costly.
The FTC says the drugmakers are rigging the market and costing consumers and insurers (public and private) billions of dollars.
Sometimes the Supreme Court chooses to hear a case if there is a difference of opinion between circuits within the U.S. Court of Appeals. The FTC had lost in several circuits. But in the Third Circuit, based in Philadelphia, the FTC found judges that agreed with its argument.
The FTC's request to the Supreme Court to hear the case is here.
The Third Circuit of the U.S. Court of Appeals decision in the matter is here.
But last week started with another case, this one in the Second Circuit in New York, that could alter the whole concept of the U.S. Food and Drug Administration prohibiting drug companies from promoting medicine for uses not explicitly approved by the FDA.
Alfred Caronia was a sales rep for Orphan Medical, Inc. and promoted the drug Xyrem for "off-label" use. He was convicted of a crime, but two of the three judges agreed with Caronia's appeal on First Amendment grounds. Those judges cited last summer's Supreme Court decision in Sorrell v. IMS Health that disallowed a Vermont law prohibiting the disclosure of prescribing trends of doctors to pharmaceutical companies when the information could go elsewhere.
Judge Debra Ann Livingston dissented with the application of law, but also said the decision "calls into question the very foundations of our century-old system of drug regulation."
She suggested that without that system of drug regulation, the American marketplace will see a return of unproven and unsafe concoctions.
"To put the matter in practical terms," Livingston wrote, "it is because of the 'intended uses' principle that hardware stores are generally free to sell bottles of turpentine, but may not label those bottles, 'Hamlin’s Wizard Oil: There is no Sore it will Not Heal, No Pain it will not Subdue.' ”