Media

Press Release

FDA Standards and Foreign Inspections

All Medicines Should Follow the Gold Standard Adhered to by the Highly Regulated Brand and Generic Pharmaceutical Industries

Background

FDA-approved prescription drug manufacturers -- brand and generic -- operate in a highly regulated environment to ensure the safety and efficacy of medicines taken by millions of Americans every day. Congress and the FDA have promulgated strict rules governing the development, manufacture, approval, packaging, marketing and post-marketing surveillance of FDA-approved prescription drugs. In other words, FDA has in place robust quality product-specific standards that must be adhered to from lot-to-lot as well as rigorous good manufacturing standards for facilities that manufacture and supply prescription drugs and the active ingredients thereof. Both brand and generic prescription drug manufacturers adhere to the gold standard of review and regulation -- a standard that works to ensure safety and efficacy.

Unfortunately, not all medicines are subject to this gold standard. Within the United States, there are two different standards -- one for the highly regulated, FDA-approved brand, generic, and biological prescription drugs and one for the drugs sold in the U.S. without FDA’s approval. These unapproved and unregulated products include, among others, grandfathered products, certain prescription drugs sold over the Internet, and over-the-counter (OTC) drugs -- products that fall outside of the highly regulated prescription drug market. While FDA-approved brand, generic and biological prescription drugs are subjected to a rigid application-based approval process,* these other products are marketed either under a minimally regulated system or no regulatory system at all. Specifically, numerous OTC drugs have been on the market for years and some pre-date the laws that require proof of safety and effectiveness before marketing. Years ago, the FDA implemented regulatory monographs for some classes of OTC products, but the fact is that the unregulated and OTC drug markets continue to fall between the cracks. Finally, another issue of great concern is the importation of counterfeit medicines -- products that will provide consumers with substandard medicines at best.

It is critical that the domestic, closed pharmaceutical distribution system be strengthened to address existing weaknesses in the oversight of the unapproved and unregulated drug market to protect consumers from substandard and potentially harmful medicines, and and to prevent counterfeit products from entering the U.S. drug supply. There should be ONE, HIGH QUALITY STANDARD implemented and enforced.

The Generic Pharmaceutical Industry: Going the Extra Mile to Ensure Safety and Efficacy

As a result of FDA regulations, the brand and generic FDA-approved pharmaceutical supply chain is perhaps the most rigorously tested process in product manufacturing in the world. The generic industry also goes the extra mile in ensuring safety and efficacy. We do so because safety is our top priority. We take seriously our commitment to honoring the public trust. We also have a legal responsibility. Our industry faces strict criminal penalties if we do not adhere to the rigorous standards placed on us. And that’s the way it should be.

The generic industry invests millions of dollars annually into state-of-the-art research, development and manufacturing facilities; maintaining complex operational infrastructures to ensure product safety and efficacy; retaining highly skilled and dedicated employees; and developing and implementing extensive quality control systems. Over the last decade, our highly regulated industry has demonstrated its commitment to adhering to the highest quality standards for prescription drugs in the world -- and our compliance track record over the last five years is second to none.

Our industry also holds our suppliers and active pharmaceutical ingredient suppliers to the highest standards. The finished dosage form manufacturers are the most highly regulated aspect of the current system because of the FDA requirements related to product development, application filing, final approval and post-marketing surveillance. Our companies conduct: (1) extensive auditing of suppliers; (2) validation testing of incoming materials; and (3) strict due diligence programs to comply with FDA regulations.

The generic industry also does not face the same counterfeiting problems that exist in other sectors where prices and demand are high.

Congressional and FDA Action is Needed

There is clearly a problem when different sectors of the pharmaceutical system follow different standards for ensuring safety and efficacy. The fact is that -- at a minimum -- all sectors should be made to adhere to the strict standards of the highly regulated brand and generic prescription pharmaceutical industries.

Safety must always be priority number one. GPhA has long supported measures to strengthen safety standards across the board and to deal with the problems posed by unregulated, counterfeited medicines. FDA needs to regulate the unregulated market and crack down on counterfeit drugs and Internet pharmacies. The key to this objective is providing FDA the resources it needs to do the job.

When it comes to inspections, we believe that what should be established is compliance facility and product inspections at the same rate and to the same extent as those conducted in the U.S. -- inspections that will provide Americans with the necessary assurances that these facilities have the proper core competencies, laboratories, and operational manufacturing and quality systems to ensure total control over every facet -- from research to manufacturing -- for every medicinal product that enters the U.S. market.

This system would provide a means to identify potential system deficiencies and undertake corrective action before products become adulterated. While the generic prescription industry already abides by strict regulations, we would be more than willing to do our fair share in supporting a more robust FDA foreign inspection program. However, we also believe that all parties who wish to do business in the U.S. at any level must also step up to the plate and pay their fair share as well.

GPhA supports the goal of Congressman Dingell’s Food and Drug Import Safety Act of 2007 -- a bill intended to enhance and modernize FDA’s foreign drug inspection and oversight programs. However, while we strongly support strengthening FDA’s foreign inspection program to ensure that FDA’s quality standard remains the world’s gold standard, we are concerned that, as currently structured, the bill does not adequately place responsibility on those who need to be accountable with the FDA’s gold standard approval process. To truly make the process work, the foreign inspection program must make manufacturers of all products do their fair share in ensuring adherence to strict quality standards.

Americans should have the assurance that all medicines -- regardless of the type of medicine and where they are developed, manufactured, and stored -- adhere to the world’s gold standard. Congress and the FDA must ensure that everyone -- not just the highly regulated brand and generic prescription industries -- play by the rules.

* Brand drugs are approved through submission of a New Drug Application (NDA); generic drugs are approved through submission of an Abbreviated New Drug Application (ANDA); biological products are approved through submission of a Biological License Application (BLA).

Search Press Releases