GMP high on agenda as FDA reaches 'critical period'

Related tags Fda Pharmacology

Calling the next six months 'a critical period', the US Food and
Drug Administration's Acting Commissioner Lester Crawford has
unveiled a lengthy list of agency priorities, including continued
work on Good Manufacturing Practice (GMP) standards.

At a conference at the National Press Club, Crawford stressed the importance of GMPs in both the pharmaceutical and food industries, and noted that regulation of these in both the sectors is in need of updating.

"GMPs in the medical product arena have not incorporated modern quality thinking. And in the case of the food industry they have not been refreshed in nearly two decades,"​ he told the conference.

This month marks the two-year anniversary of the FDA's new effort to bring GMPs in the pharmaceutical industry up to date, and the end is now in sight, with new guidelines due to be finalised this coming autumn.

"GMPs are not only vital to business success; they are also essential to FDA and they are essential to the public health,"​ he said. But it is impossible to inspect every prescription drug pill, every diagnostic testing kit, every animal vaccine, and every food parcel that is manufactured or processed.

"By ensuring the best possible manufacturing practices through tested quality improvement modalities, the agency can assure products of high quality,"​ noted Crawford.

Meanwhile, he noted that along with its work on food GMPs the FDA is also finalising the first-ever GMP guidelines for dietary supplement manufacturers.

The Acting Commissioner also highlighted a new effort that is designed to speed up the regulatory approval process for new drugs and medical technologies.

This new effort ties in with the agency's ongoing 'Innovation Initiative', which has already resulted in a pilot programme to test earlier communication with product manufacturers, a cementing of the FDA's partnership with the National Cancer Institute and the establishment of an Oncology Office within the agency to foster innovation in the treatment of cancer.

Over the next six months, said Crawford, this initiative will be joined by a new framework for 'quality systems', a series of recommendations regarding best management practices for FDA's drug review process.

In the meantime, the FDA is developing an applied science toolkit containing scientific and technical methods such as animal and computer based predictive models, biomarkers for safety and effectiveness and new clinical evaluation techniques. The goal is to help predict eventual product failures early during clinical trials and to reduce developmental uncertainties in three critical product areas: product safety, medical utility and manufacturing potential. These efforts are being conducted under the Critical Path Initiative.

In the late autumn, continued Crawford, the agency will announce a National Critical Path Opportunities List, which will pinpoint those areas of product development that could benefit most from innovative approaches and emerging technologies.

And later this year, the FDA intends to issue guidance regarding new requirements for screening and proof of concept Investigational New Drug studies. This will help facilitate the identification of the most promising drug candidates to develop.

Generic drugs remain a priority to make lower-cost medicines available to as many people as possible, he added, and moves are afoot to expand the areas in which investigational drugs can be given to patients facing serious and life-threatening diseases.

Changes to labelling guidelines

Finally, the FDA will be finalising the agency's proposed changes to prescription drug labelling to make the label more user-friendly for both patients and health care practitioners. These revisions will help reduce medication errors, said Crawford.

The idea is to make the label less dense and cluttered by reordering certain sections, setting minimum graphical requirements, and including both 'highlights' of prescribing information and a table of contents.

"The revisions will be a great assist toward the day electronic labelling will be fully accomplished,"​ according to Crawford.

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