The US Federal Trade Commission has said it is planning to subpoena 190 pharmaceutical companies as part of an investigation into possible anticompetitive practices in the prescription pharmaceutical industry.
The subpoenas, which require Office of Management and Budget approval, form the basis of an investigation into the sale of so-called ‘authorised generics’, which are manufactured by the original developer of the drug, but sold by a generics firm under license.
The FTC first agreed to look into the matter last November, after a request was made by US Senators Chuck Grassley, Patrick Leahy and John D Rockefeller IV.
“In most cases, these products are identical products, rolling off the same assembly lines, yet one bears the brand label, the other the generic label,” according to the USA-based Generic Pharmaceutical Association (GPhA).
The suggestion is that the practice is stifling competition by acting as a disincentive for other companies to develop their own versions. In some cases, it is alleged, the authorised generic steals a march on its competitors by being made available during the 180-day exclusivity period awarded to other generics companies under the first-to-file legislation in the USA.
“Recently, brand-name drug makers have begun marketing authorized generics at exactly the same time the generic first-filer is beginning its 180-day marketing exclusivity period, leading to questions about the effects of authorised generics on pharmaceutical competition,” according to the FTC.
Moreover, the authorised products are treated as generics by the Centers for Medicare and Medicaid Services (CMS), claims the GPhA, which says this skews figures compiled for best-price calculations, the basis for the CMS’ purchasing negotiations, to the detriment of the federal and state government programmes.
If the go-ahead is given, a final report from the FTC on the matter will appear next year.
