Authorized Generics May Draw More FTC Scrutiny, Expert Says
Unfortunately, you need to be a subscriber to get the story via the link, so here’s a portion of the story (below). The gist is that FTC might be scrutinizing authorized generics more closely. If so, this could lead to a lawsuit test of the practice. If this happens, it would represent an about-face of FTC’s current position supporting the authorized generic practice. As you might know, I am firmly against the practice from a public-health standpoint, as it leads to dis-incentives for independent generic makers to take the risks needed to bring new generics forward quickly. If left unchecked, the practice could eliminate the indpendent generic manufacturer as we know it. –FJC
From FDA News, Oct. 5th edition:
AUTHORIZED GENERICS MAY FACE INCREASED FTC SCRUTINY
Although a growing number of generic drugmakers appear willing to participate in the authorized generics market, the controversial practice may soon face increased scrutiny from the FTC, according to an industry expert.
David Balto, an attorney with Robins, Kaplan, Miller and former policy director in the FTC’s Bureau of Competition, said regardless of whether some generic firms are in favor of authorized generics, the anticompetitive nature of the business strategy is something the FTC is expected to monitor closely.
Congress has already asked the FTC to investigate the competitive effects of authorized generics, Balto noted, citing a May 9 letter by Sens. Chuck Grassley (R-Iowa), Patrick Leahy (D-Vt.) and Jay Rockefeller (D-W.Va.) that asks the FTC to review the practice. The FTC could very well grant the request, said Balto, who noted the agency has undertaken several initiatives to address generic competition issues, including a study on generic drugs in 2002.
The issue of authorized generics remains a polarizing one among generic drugmakers, with some firms electing to stay out of the market and others jumping ship to form partnerships with brand firms. William Kennally, president of Pfizer’s generics subsidiary Greenstone, said a schism has formed between the companies that support the practice and those that don’t.
