Malli Loses Suing FDA - screw them sell it anyway

[speed for kids]

FDA sez Malli drug not the same... Malli sues... Malli loses

Mallinckrodt has lost a lawsuit that challenged a Food and Drug Administration reclassification of one of its generic drugs.

The U.S. District Court in in Greenbelt, Md., dismissed three of Mallinckrodt's five claims against the FDA and ruled in favor of the federal agency on the other two claims.


Mallinckrodt is considering an appeal, the company said in a Securities and Exchange Commission filing on Wednesday.

At issue was whether Mallinckrodt’s generic drug, methylphenidate ER, is a true equal to its brand name counterpart. In November, the FDA reclassified the drug so it could no longer be automatically swapped out at the pharmacy level for patients seeking a cheaper alternative to the brand name.

Mallinckrodt argued it essentially was like pulling the drug from the market, and, officials said, the law requires due notice and a hearing before a drug can be pulled.

The FDA argued the drug was not a true substitute to the brand name, citing numerous adverse events and complaints about the drug that 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.

 

[anonymous]

so typical, make a crap product and try to make money. This is a horrible place with horrible people. they should all be ashamed!!!!

 

[anonymous]

FDA? Hahaha who's that? They don't matter, we are Mallinckrodt we make the rules.

 

[BX = No Sales]

Earlier this week, the U.S. District Court for the District of Maryland unsealed a 73-page Opinion handed down on July 29, 2015, along with an Order, in a challenge brought by Mallinckrodt Inc. (“Mallinckrodt”) last November after FDA downgradedfrom “AB” to “BX” the Therapeutic Equivalence (“TE”) rating for Mallinckrodt’s generic version of CONCERTA (methylphenidate HCl) Extended-Release Tablets, 27 mg, 36 mg, and 54 mg, approved under ANDA 202608. According to FDA, “an analysis of adverse event reports, an internal FDA re-examination of previously submitted data, and FDA laboratory tests . . . have raised concerns that the products may not produce the same therapeutic benefits for some patients as the brand-name product, Concerta. . . .”

According to Judge Chasnow:

FDA’s reclassification of Mallinckrodt’s TE rating in the Orange Book did not deprive Mallinckrodt of its ANDA approval. Mallinckrodt has argued that because of its new TE rating in the Orange Book pharmacists will no longer automatically substitute its drug for Concerta and fewer customers will purchase its drug, resulting in a loss of market share and profits. Mallinckrodt has provided some evidence . . . of the anticipated impact on its market share, shortly following the TE rating change. . . . Evidence of the impact on its market share and sales, however, does not show that its property right — the ability to sell its product lawfully — has been deprived by FDA and instead, shows third party and market reactions to FDA’s reclassification. . . . FDA did not compel the pharmacists or Mallinckrodt’s customers to change their dispensing and buying habits. It merely changed the drug’s TE classification in the Orange Book in accordance with its duty to provide updated drug information to the public on a regular basis.