OGD MAY COMMUNICATE WITH GENERIC DRUG FIRMS VIA EMAIL, TELEPHONE
The Office of Generic Drugs (OGD) will start communicating with generic drug applicants via telephone instead of by letter whenever possible to speed up drug application reviews and whittle down the application backlog, OGD director Gary Buehler said at a recent industry conference.
The office plans to use telephone calls to notify applicants of deficiencies in abbreviated new drug applications (ANDAs). OGD may also use "secure" email to inform applicants of deficiencies, Buehler said recently at the annual meeting of the Generic Pharmaceutical Association (GPhA) in Boca Raton, Fla.
"It really is big news in our office," Buehler said, citing the generic drug scandal of 1989, when the FDA "clamped down on a lot of communication." In 1989, an investigation found that some generic drug companies were bribing FDA officials in return for having their drug applications approved. Concurrently, officials ignored applications by generic drug companies that weren't making payoffs. OGD subsequently decided to restrict phone communication and rely on letters, which creates a paper trail of exchanges between FDA staff and drugmakers.
The communications change means OGD will no longer have GPRA (Government Performance and Results Act) goals, Buehler said. Under GPRA, OGD sent each applicant a letter detailing any application deficiencies. Buehler said the GPRA goal actually decreased the number of first-cycle approvals because FDA staff had to send the letter within 180 days of receiving the application.
"Many times we were up against that 180-day goal so it was easier to get the deficiencies, put them in a letter and fax it to you on day 179 than pick up the phone and discuss them with you," he said. "No longer having this goal will allow us to contact you by telephone during the first cycle to try to resolve a lot of the minor deficiencies and get you out of the office with an approval in 9-10 months."
OGD will also rely on other tactics to eradicate the backlog, including an early review of drug master files (DMFs) submitted by innovator companies. The information in a DMF may be used to support a generic drug application. OGD also will continue reviewing applications in "clusters," during which it simultaneously reviews several generic drug applications for the same product.