File this under “Not so fast!”

Two drug makers — Mallinckrodt (MNK) and Lannett — are fighting the US Food and Drug Administration over a plan the agency announced last week to withdraw their generic versions of the Concerta pill for attention deficit disorder. Mallinckrodt is trying to contest the move in court, while Lannett plans to seek a hearing in hopes of convincing the agency to change its mind.

The agency took this step after determining the generic drugs were not equivalent to the brand-name pill, an issue that actually arose two years ago and prompted the FDA to downgrade regulatory ratings for the copycat drugs. This was an unusual move and meant that the generic versions, which contain the same active ingredient as Concerta, could no longer be automatically substituted at pharmacy counters.

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The FDA adopted this position after reviewing adverse event reports, data previously submitted by the drug makers, and running laboratory tests. At the time, the agency concluded that, in some people, the two generic versions may be absorbed in the body at a slower rate and, therefore, may not yield the desired effect.

This shifted the onus to the drug makers to provide additional data.

Mallinckrodt, however, never did so, as the FDA pointed out in a Federal Register notice last week. Instead, the drug maker two years ago filed a lawsuit challenging the right of the FDA to downgrade its regulatory rating. The lawsuit was dismissed earlier this year, but the company filed an appeal this past summer, and a flurry of motions was submitted over the past few days.

In one motion, the FDA argued that the Mallinckrodt challenge is now moot, since the agency continued to evaluate its generic version of Concerta and determined that the pill should be withdrawn. For its part, the drug maker countered that its “challenge to the bioequivalence guidance is very much alive” and, therefore, the case should continue.

In its initial lawsuit, Mallinckrodt had argued that the FDA failed to provide sufficient notice of its decision and violated its constitutional rights. Moreover, the company noted that the FDA acknowledged there were no safety issues and patients should continue taking the generics if they are not experiencing problems.

[UPDATE: A Mallinckrodt spokeswoman later wrote us to say that the drug maker is “actively gathering additional information and data to submit to the FDA to support our request for a hearing on the matter. The time frame for submitting all of this information is mid-December.” She also reiterated that the FDA has not conveyed any safety concerns.]

Meanwhile, Kremers Urban Pharmaceuticals, which was sold to Lannett last June, submitted more data to the agency. It would appear, though, that the additional information did not persuade FDA officials to change their minds, since the agency last week issued its notice indicating it would pursue a product withdrawal. Now, Lannett plans to seek a hearing with the FDA.

“We intend to review the scientific rationale for FDA’s most recent position and compile the scientific evidence to convince FDA’s Office of Generic Products that our product should continue to be marketed,” said Arthur Bedrosian, the Lannett chief executive, in a statement. “This will preserve patient and prescriber choice, and maintain an affordable alternative drug on the market.”

The FDA downgrading narrowed the market. Besides Concerta, which is sold by Johnson & Johnson (JNJ), the only option available is a so-called authorized generic, which is now marketed by Impax Laboratories and can be substituted for the brand-name pill. Impax recently purchased the rights to market the generic version.

Meanwhile, Mallinckrodt reported that sales of its generic version have been declining. For the nine months ended June 30, sales fell 29 percent to $80 million from about $112 million during the same period a year earlier.

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  • Memo to Mallinckrodt and Lannett: Bioequivalence is not defined as “in the ballpark” much as you would like it to be. The efficacy of these copycats wears off after about seven hours, just in time for little Johnny to miss his stop on the school bus route.

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