FDA Increases Regulatory Collaboration, Inspections to Improve Drug Quality and Safety

Earlier this month, the US Food and Drug Administration, together with its European and Australian counterparts, released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration with regard to drug quality and safety.

One report reviewed the Good Clinical Practice (GCP) initiative and assessed the success of information-sharing and collaboration on inspections relating to clinical trials.

The second report reviewed the Active Pharmaceutical Ingredients initiative and presented results of the information-sharing among the FDA, Australia's Therapeutic Goods Administration and for Europe, the EMA, France, Germany, Ireland, Italy, the United Kingdom and European Directorate for the Quality of Medicines & Healthcare (EDQM). Based on the shared information, the FDA was able to refine its decisions, such as whether to postpone or expedite certain inspections, and in some cases also prohibited imports into the US of a firm's products based on negative findings from a European inspection. According to the FDA, the information-sharing and collaborative inspections were important milestones in establishing a sense of mutual trust and common purpose among the drug regulatory agencies involved.

In June, the FDA released Pathway to Global Product Safety and Quality, a report which unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain. This FDA report calls for the agency to:


transform the way it conducts business,


build upon its ongoing collaborations with its regulatory partners around the world, and


act globally in order to promote and protect the health of US consumers.

Over the weekend, The New York Times ran a great article that sheds even more light on this important topic.

As explained in the article, more than 80 percent of the active ingredients for drugs sold in the US are now made abroad, mostly in a "shadowy network" of facilities in China and India. These manufacturing facilities are rarely visited by government inspectors in fact, at its current pace, the FDA would need more than 13 years to inspect every foreign drug plant that exports to the US.

Fortunately, proposed legislation aims to change all that. The New York Times reports that after decades of failed attempts, the federal government and the generic drug industry have reached an agreement that will lead to routine inspections of these overseas plants, potentially transforming the enormous global medicine trade. The agreement is expected to pass Congress. From the article:

Under the landmark agreement, expected to be completed within weeks, generic drug companies which make 75 percent of the prescription medicines sold in the United States would pay $299 million ain annual fees to underwrite inspections of foreign manufacturing plants every two years, the same frequency required of domestic plants.

Self-interest helped drive the agreement because the industry will not only get speedier approvals of new products as part of the deal but also may avoid scandals involving tainted medicines, which tend to hurt confidence in the entire industry.

It's worth noting that the agreement applies to generic drugs only. It will not affect the making of over-the-counter medicines or vitamins, nor will it change the FDA's oversight of name-brand prescription medicines.

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