Pharma’s Anti-Competitive Tactics That Stymie Generics Drugmakers Targeted By Officials, Lawmakers
Generic drug developers need samples of brand-name drugs to show that a generic copy is equivalent to the original, but the drug companies are refusing to provide samples of their products. In other pharmaceutical news: an appeals court hands the industry a victory in price gouging case; a former Mallinckrodt employee claims she was fired for warning company about illegal sales practices; and a shortage of EpiPens outside the U.S.
The New York Times:
Drug Company ‘Shenanigans’ To Block Generics Come Under Federal Scrutiny
Trump administration officials, seeking ways to lower drug costs, are targeting pharmaceutical companies that refuse to provide samples of their products to generic drug companies, making it impossible to create inexpensive generic copies of a brand-name medicine. Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, said recently that drug makers must “end the shenanigans” that prevent competing products from reaching the market. (Pear, 4/14)
Stat:
Maryland Law That Punished Generic Price Gouging Is Ruled Unconstitutional
In a victory for the pharmaceutical industry, a federal appeals court panel ruled that a Maryland state law that was enacted to punish generic drug makers for price gouging is unconstitutional. In explaining its decision, the panel sided with a trade group for generic drug makers that argued the state law violates interstate commerce by giving Maryland officials the right to govern business outside the state, effectively providing “unprecedented powers to regulate the national pharmaceutical market.” (Silverman, 4/13)
Stat:
Former Mallinckrodt Employee Alleges The Ingredients In A Best-Selling Drug Are A Mystery
In a sensational lawsuit, a former Mallinckrodt (MNK) employee claims that she was fired for repeatedly warning the drug maker about a host of allegedly illegal activities designed to boost sales of a key drug. Those practices included running a “sham” patient assistance program and refusing to provide payers with clinical data that would be used for making coverage decisions. Moreover, executives were allegedly unaware of the ingredients in the best-selling Achtar drug, which is used to treat infantile spasms and often prescribed for more than a dozen other maladies. (Silverman, 4/13)
Reuters:
EpiPen Shortages Seen In Canada, UK But U.S. Supply Intact
Mylan N.V.'s emergency allergy antidote EpiPen is in short supply in Canada and Britain, but remains available in the United States, the treatment's manufacturer said on Friday. EpiPens deliver potentially lifesaving doses of the generic drug epinephrine, via an automatic injector that a patient or caregiver can administer in the event of severe allergic reaction."We are shipping product. Currently there is no shortage in the U.S.," said Steve Danehy, a spokesman for Pfizer Inc, which produces the global supply of EpiPens for Mylan out of a single facility near St. Louis, Missouri. (Berkrot and Erman, 4/14)