After nearly three years of controversy, President Obama has signed a law that resets approval dates for some medicines that contain controlled substances. The goal is to streamline the process used by the US Drug Enforcement Agency to place prescription drugs that are controlled substances on a list of medicines for which distribution is restricted.
In doing so, the new law ensures that a company offering such medications will not effectively lose time from a five-year period under which it can exclusively market the drugs.
Drug makers have griped they are often at a competitive disadvantage, since controlled substances must first be placed on the DEA list before they can reach pharmacies. Companies have complained the process is often lengthy and hampers their ability to take advantage of a five-year marketing exclusivity period following Food and Drug Administration approval during which generic competition is delayed.
The law, which is known as the Improving Regulatory Transparency for New Medical Therapies Act, would require the DEA to list a drug within 90 days after receiving notice from the FDA and permit marketing exclusivity to begin when the DEA allows a drug to be marketed.
The law will “bring much-needed certainty to the scheduling process and give patients quicker access to new therapies by setting timelines by which the DEA must schedule new drugs,” said Orrin Hatch, the Republican senator from Utah, in a statement when the Senate passed its version of the bill last month.
The law has its genesis in a confrontation between Japanese drug firm Eisai and the FDA. Twice in 2012, the drug maker won regulatory approval of two new drugs — the Belviq diet pill and the Fycompa epilepsy medicine — but launches were delayed. The drugs are controlled substances, which meant Eisai could not market them until the DEA placed them on restricted distribution lists.
Specifically, the FDA approved Belviq in June 2012, but the drug was not listed by the DEA until June 2013. And Fycompa was approved by the FDA in October 2012, but was not listed by the DEA until January 2013, although the final scheduling on the DEA list occurred in January 2014. The delays frustrated Eisai because the five-year marketing exclusivity was ticking away.
So in 2013, the drug maker filed a citizen’s petition that asked the FDA to extend the exclusive marketing periods for both drugs in order to compensate for the lost time. The FDA refused. After the FDA denied the request, Eisai last year filed a lawsuit in hopes of forcing the FDA to do so, but a federal judge this past September tossed the case. By then, however, the law was making its way through Congress.
The pharmaceutical industry, no doubt, will welcome the law, although to what extent Eisai is helped is unclear. “While the Act clearly applies to future instances in which DEA delays cut into a company’s period of exclusivity, it’s unclear to us whether or not the Act will have any retroactive effect to apply to cases such as Fycompa and Belviq,” wrote Kurt Karst of the FDA Law Blog.
We asked Eisai for comment and will update you accordingly. [UPDATE: An Eisai spokeswoman wrote us on Dec. 1, that the company is “pleased” the law was signed].