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.
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
Generics Rule in India
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
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