Last October, when the FDA handed down an approval for its new epilepsy drug Fycompa, the Japanese pharma company Eisai had hopes of moving fast to roll out a blockbuster marketing campaign. But an unfunny thing happened on the way to the marketplace: The DEA has yet to complete the classification process--7 months after Eisai filed with the agency.
Now Eisai has filed a petition in federal appeals court to get the judicial branch to hurry along the regulatory side of government. And it's organized substantial support from the patient community to make itself heard loud and clear in Washington, D.C., where the drug industry has been growing increasingly restless as the time it takes for the DEA to provide a classification for a controlled substance--something it's responsible for when drugs are considered ripe for abuse--grows longer and longer.
According to Eisai, the DEA's classification process has swelled from a simple 49-day process to an average of 238 days. And this isn't the first time Eisai has had cause to complain. The DEA also dragged its feet longer than normal classifying Arena's weight drug Belviq, which Eisai is marketing.
PhRMA has chimed in to condemn the trend.
"Excessive delays in DEA review can not only negatively impact patient access, but also discourage biopharmaceutical research companies from pursuing the types of medical innovation that may lead to medicines requiring DEA scheduling," Mit Spears, the organization's general counsel, told the Wall Street Journal.
Patient groups aren't happy, either.
"People with epilepsy, their caregivers, or parents of children with epilepsy find it very frustrating to wait for an additional treatment option for seizure control due to DEA delay," said Phil Gattone, the CEO of the Epilepsy Foundation. "It is even more disheartening to know that the system is not required to have a clear timeline for consumers."
In its petition for a writ of mandamus, Eisai claims that the DEA has "unreasonably" and "egregiously" delayed the scheduling of Fycompa, "a delay which means that thousands of potential patients suffering with partial onset seizures--a serious medical condition for which there is great unmet medical need--cannot obtain the drug," says the company's release. "The papers also challenge the justification for the delay and highlight the lack of any timetable, predictability, or transparency related to the DEA's scheduling process. In addition, it explains that the DEA's delay also continues to harm Eisai by preventing it from launching Fycompa in the United States even though Eisai demonstrated to the satisfaction of the FDA that the drug is safe and effective when prescribed in accordance with its labeling."
It took a new law, but the FDA has responded to lingering complaints of its time-consuming review process. Perhaps an incipient industry lobbying effort could gain similar results with the DEA.
- here's the release
- read the story from the Wall Street Journal
Japanese pharma giants launch $100M global R&D initiative
Eisai pulls Fycompa in Germany to protest pricing
Eisai fires back at G-BA rebuff of Fycompa