Changing Regulatory Requirements - Part 2 - Food & Drug Administration Safety and Innovation Act and Product Quality

This blog post is a continuation of an earlier post about updated European Union regulations, and is going to examine the impact of the US Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA is an act that was approved by both houses of the U.S. Congress and signed into law by President Obama on July 9, 2012.  This is a wide ranging law that reauthorizes user fees for pharmaceutical (PDUFA) and medical device products (MDUFA), as well as new user fees for generic drugs and biosimilars.  The act also contains provisions that have direct impact on quality assurance; this blog post will focus on these specific provisions.

FDASIA directs the FDA to create a unique facility identifier (UFI) system to electronically store registration and listing information.  UFIs will be required for all companies and sites involved in the manufacturing and distribution of drugs, including excipient manufacturers, active pharmaceutical ingredient manufacturers, importers and distributors.  If a drug or device is from or has a component from an unregistered facility, it is to be labeled misbranded.  It is a violation of federal law to ship misbranded products in interstate commerce or to import these products.

Congress has also authorized increased funding for FDA inspections.  All of the above mentioned types of companies are subject to FDA inspection.  This law also states that drugs, components and ingredients will be misbranded if manufactured at any establishment that “delays, denies or limits inspection or refuses to permit entry or inspection.”  In conjunction with this, FDA is using a new risk-based standard of admission and screening for imported drugs and ingredients.

FDASIA also authorizes foreign government regulatory inspections from certain authorities to be recognized by FDA as if they conducted that inspection.  At an industry conference in September 2012, FDA representatives stated that they have already taken enforcement action based on non-FDA inspections.  The law permits FDA to conduct inspections on a “risk-based” schedule.

So what does this mean for the pharmaceutical and medical device industries?  First, they must make sure the suppliers and contractors in their supply chain have a UFI and have not had their products misbranded due to a poor inspection by FDA.  Companies need to make sure their suppliers, distributors and contractors follow GMPs in their processes, which means quality audits need to be conducted.

Quality and regulatory units also should, as part of their Enterprise Quality Management System (EQMS), track and manage not only audits they conduct, but also regulatory audits conducted at all company sitesas well as their contractors sites.  With FDA recognizing foreign inspections, companies need to have a global enterprise-wide repository for these inspections, findings and commitments.  In addition to the FDA taking regulatory action against a manufacturing site based on findings from a foreign regulatory agency, they also use foreign inspections to determine where to perform inspections.  Within weeks, FDA, using the risk-based inspection methodology, may arrive at a US plant of the same company, with the foreign inspection in hand, to see if the issues found are systemic across the company.  No longer are sites islands.  The worldwide regulatory authorities expect companies to have enterprise-wide systems in place, where problems discovered at one site are corrected globally wherever the same conditions exist.  Besides meeting regulatory expectations, implementing a global EQMS makes business sense and is proven to save companies measurable money and assure a safer product is delivered to market.

The pharmaceutical and medical device industries are truly global, supplying needed life-saving products to all corners of the world.  These products are made of materials and components also supplied from companies worldwide.  Now that FDA and other nations’ regulatory authorities are cooperating and sharing information, they too have become global, and in a way have leveled the playing field.

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