In November, the U.S. Food and Drug Administration gave Mallinckrodt Pharmaceuticals an ultimatum: Either prove its generic version of a popular drug was the same as the brand name, Concerta, or voluntarily remove it from the market.
The FDA gave the drugmaker, which has U.S. headquarters in Hazelwood, six months to make either move. But time is up and its drug, which is used to control the symptoms of attention deficit hyperactivity disorder, or ADHD, is still on the market.
Now, Mallinckrodt is taking on the FDA in federal court in a case that industry and legal experts say could have a larger impact on the pharmaceutical industry.
At issue is whether Mallinckrodt’s generic drug, methylphenidate ER, is a true equal to its brand name counterpart. The FDA argues it’s not, citing numerous adverse events and complaints about the drug were reported after its December 2012 approval. The FDA conducted its own studies and found the generic is delivered at a slower rate than Concerta, the brand name drug made by Janssen Pharmaceuticals, a division of Johnson & Johnson.
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That’s a problem, say doctors, because the drug is supposed to allow patients to take a single dose to control ADHD symptoms instead of multiple doses throughout the day. The extended release formula is particularly important for children in school. If the drug is delivered too slowly, or wears off too quickly, it’s not effective.
After the FDA’s findings on bioequivalence, it changed the classification of Mallinckrodt’s drug, essentially making it harder for patients to obtain. The FDA’s decision meant the drug could no longer be swapped out at the pharmacy level for a patient seeking a cheaper version when prescribed the brand name drug.
Mallinckrodt argues the move essentially pulled the drug from the market. The drugmaker says, according to its suit filed Nov. 17, that if a drug is pulled from the market, the law requires due notice and a hearing.
The stakes are big. The generic drug generated revenue of $210 million for Mallinckrodt for the fiscal year ended Sept. 30, 2014. Mallinckrodt reported $2.5 billion in net sales for fiscal 2014.
A 2014 report by Express Scripts found that in 2012 almost 4.8 million privately insured Americans had taken a drug to treat ADHD. Express Scripts, the St. Louis County-based pharmacy benefits manager, described the increase in usage since 2008 by adults and children as a “meteoric rise.”
If Mallinckrodt prevails in its case it “will become much more time-consuming and resource-consuming for the FDA to reclassify generic drugs,” said Patti Zettler, a former FDA attorney and associate professor at Georgia State University College of Law.
Zettler says a Mallinckrodt victory would create a precedent that could mean that every time a generic drug is reclassified, the FDA would have to hold a hearing.
A victory could also damage the reputation of the generic market, said Ronny Gal, an analyst with Sanford Bernstein.
“The generic market works well because the drugs are viewed as interchangeable with the brands,” Gal said. “If drugs which are just close become part of the market, it would ruin that confidence.”
In the Mallinckrodt case, the FDA says the drug is safe but questions its efficacy.
“Evidence suggests that Mallinckrodt’s products may deliver the drug in the body at a slower rate during the seven- to 12-hour range,” the FDA alleged in a Nov. 20, 2014, filing, opposing Mallinckrodt’s suit filed just days prior. “The diminished release rate may result in the product not having the desired therapeutic effect.”
That’s a problem, says Dr. Paul Glaser, a child psychiatrist and professor at Washington University School of Medicine.
“What if a third-grader, who is finally getting good grades, and they get switched to the generic and they start to fail,” Glaser asked. “That to me is a safety concern.”
In a statement, the company said, “we expect our medications to continue to be available for physicians and patients for the foreseeable future.”
The statement also says that Mallinckrodt believes the methylphenidate ER medicines are “safe and effective” and have met “all quality specifications and the regulatory requirements originally defined by the FDA.”
The company sought a temporary restraining order to block the FDA move, but it was denied on Nov. 25, 2014 in the District Court of Maryland by Judge Deborah K. Chasanow, according to federal court records.
While the case continues, Mallinckrodt’s version of the drug remains on the market.
In November, the FDA also made the same reclassification of another generic version of Concerta made by Kudco Ireland Ltd. The drugmaker’s U.S. agent submitted new bioequivalence studies to the FDA in June, according to a press release.
The only other generic version is made by Janssen but marketed by Actvais under a licensing agreement.
Express Scripts still dispenses Mallinckrodt’s drug if it’s specifically requested, although it’s filling more prescriptions for a generic version made by Actavis.
“The prescriptions that we dispense within this class have shifted significantly toward the Actavis approved generic. A few physicians still write specifically for the other generics, and we are able to accommodate those requests,” Brian Henry, spokesman for Express Scripts, said.
