FDA Chief Cites Gains Versus Backlog

 The Food and Drug Administration (FDA) recently reported major gains in its bid to reduce the backlog in pending applications filed before the agency.

FDA Director-General Nela Charade Puno said the agency has already reduced by some 3,500 the estimated backlog of about 80,000 applications left pending in the past, including those unattended to under previous administrations.

She said the FDA is set to reduce the number by 1,400 following the verification and posting of these applications in the agency’s E-Portal and subsequent action by the various FDA Centers.

Puno explained that the gains were made possible by a dedicated technical team under the direct supervision of the FDA head which undertook the evaluation and disposition of the pending applications for licenses to operate and certificates of product registration/notification.

Puno said the FDA expects to significantly clear the backlog by the first quarter of next year in line with the agency’s “Project: Zero backlog”.

Puno earlier announced that that agency has taken drastic moves to address the backlog in the processing of various applications from the agency in a bid to make way for more efficient systems and to get rid of so-called “nuisance applications”.

She also warned that the FDA will set stricter requirements for future applications “to weed out the nuisances and to enable the FDA to attend to the needs of serious and legitimate applicants”.

Puno had also earlier pointed out that the current backlog “appears to have been at the FDA for close to a decade and have been left unattended”. A large percentage of the backlog is the result of the inability of applicants to submit product registration requirements, she noted.

Puno said the moves are in line with commitments made by the FDA at the beginning of the current administration. “This follows the directive of President Duterte that the agency should be rid of inefficient and corrupt elements and that the public should be given higher standards of service,” she explained.

Puno said the backlog in the processing of applications she inherited “is also partly responsible for the proliferation of unregistered food and drug products in the black market”.

She noted that the slow process may have pushed manufacturers and distributors in the past to skip registration  which, in turn, “poses risks to the public since unregistered products have not been properly evaluated for safety and efficacy”.

The FDA head also warned that she will not allow delays in the processing of applications “that are caused by inefficiency and corruption on the part of our personnel”.

She called on applicants to report any unwarranted actions on the part of any FDA personnel that may affect the efficiency and integrity of the FDA processes.

 

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