Generic Drug Gains and Grumbles - Pharmaceutical Executive

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Generic Drug Gains and Grumbles


Pharmaceutical Executive


Shortages and competition

Generic drug companies also have suffered in the court of public opinion from manufacturing lapses and product quality problems that have led to critical shortages in important medicines, particularly for sterile injectable cancer therapies, analgesics, and anesthetics. FDA has strengthened its monitoring of shortage problems and taken steps to make alternative therapies available to patients, but low prices on these hard-to-produce drugs have deterred competitors from entering the injectables market.

Now the economic picture seems to be attracting new players to the field. Becton Dickinson (BD) recently announced FDA approval of an injectable antihistamine in pre-filled syringes, the first of a new line of pre-filled generic injectables.

Similarly, Jordan-based Hikma has expanded sterile injectable production capacity at its New Jersey plant following FDA approval of several injectable generic therapies, and Teva is expanding production of injectables at its facility in Hungary. BD acknowledges that its prefilled products will be more expensive than existing generic injectables, but claims they will be safer and easier to administer. The company is betting that providers and payers will accept higher prices for a more reliable, high-quality supply of necessary therapies.

FDA changes


Generics Rule in India
Meanwhile, FDA's regulatory program for approving new generic therapies has been shaken by a series of organizational changes affecting the Office of Generic Drugs (OGD). The head of that office, Gary Geba, departed suddenly in March after less than a year on the job (see http://pharmexec.com/ posting, March 2013), apparently unhappy about a reorganization at the Center for Drug Evaluation and Research that would combine generic and new drug review chemists in a new Office of Pharmaceutical Quality (OPQ). Ever since the OPQ proposal emerged last fall, OGD staffers have raised concerns about decimating the generic drug review process. The change also appears to counter a move by CDER director Janet Woodcock last September to elevate OGD to "super office" status directly reporting to her.

Similarly, staffers in CDER's Office of Compliance are leery about OPQ swallowing up much of its Office of Manufacturing and Product Quality. The idea is to combine operations responsible for evaluating manufacturing data in applications for new drugs and generics with those overseeing compliance with good manufacturing practices, but that seems to involve stepping on a lot of toes.

To lend stability to the situation, Woodcock recently named agency veteran Kathleen Uhl as OGD acting director. Uhl faces the tricky task of implementing a more efficient application review process, overseeing more timely field inspections, whittling down an enormous review backlog, and establishing the new generic drug user fee program. She comes to the job with experience as a CDER reviewer, as head of FDA's Office of Women's Health and most recently deputy director of CDER's Office of Medical Policy, where she was involved with negotiations related to FDA's new biosimilars program. Uhl will need all her experience navigating the drug regulatory arena to meet public demand for high quality—and affordable—generic therapies.

Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at
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