Recent news reports attacking the US drug approval process are not considering all the facts. The Food and Drug Administration (FDA) has been under fire for several years now about their regulatory processes. Some people say the FDA has been too lenient and approved unsafe products for human consumption while others say the FDA is just the opposite -- too strict. Unfortunately, the FDA is losing its international regard as the world leader in food and drug regulation as a result of so much controversy.

The FDA has been accused of some questionable acts in recent times. It is true that drug manufacturers can pay money to the FDA and receive expedited reviews for their products in development. Otherwise, expedited reviews are reserved for high-priority food and drug products, especially treatments for incurable diseases like cancer and HIV/AIDS. On one hand, this type of partnership or corporation seems to be a win-win situation for the agency and the manufacturer, and the consumer too. On the other hand, it raises suspicion because big pharma companies may gain power and profits, and their motive may be questioned as unethical.

In defense of the FDA, it is important to remember that there is a priority structure within the regulatory review and approval process. For example, a treatment for childhood leukemia will rank higher on the FDA’s to-do list than an obesity medication or contaminated surgical instruments. Drug manufacturers who seek fast approval from the FDA should develop products that are in line with the FDA’s priorities for protecting and promoting human health in the US.

A considerable number of medical device companies have expressed concerns about the FDA being too slow to approve new products for the market, and losing business to Europe where regulatory guidelines are less strict. With all fairness, medical devices and biological therapeutics are the products of modern science and the FDA may be behind the ball on the latest knowledge. This, however, is something the FDA recognizes as a major priority for the Center of Devices and Radiological Health (CDRH). Some of the strategic priorities for 2012 are to hire a Knowledge Management Director and create processes and tools to foster the innovation pathways specific to devices, companion medicine and biosimilars.

Additionally, the agency is planning to strengthen regulatory science overall. By the end of 2012, the FDA claims it will establish partnerships between public and private sectors including academia and industry innovators to shape the regulatory pathway for medical devices. Further, the CDRH is working on a Virtual Physiological Patient Project -- a computer model which will be validated for public use -- with big applications in the regulatory world.

Strategic priorities of the FDA and CDRH reflect a trend of reorganization, innovative science, transparency and expansion. While I believe the FDA does a great job of managing its numerous responsibilities, the begging notion at the back of my mind calls for division. Why not separate the FDA into two agencies: one for food and one for drugs? The two both relate to human health undoubtedly, but the regulatory processes are vastly different. Truth is, the current-day FDA does a lot of things well but nothing extremely well.

If the strategic priorities for 2012 are not met, the US biomedical and R&D industries are likely the ones who will suffer. Additonally, the longer the drug approval process takes, the more expensive the drug will be for the end user. So there is a real need to expedite ALL drug approvals; however, we need not sacrifice quality or safety for the sake of money. If a new product may cause more harm than good, the FDA would (and should) rather not approve.

Related reading:

The importance of competition and the marketplace in biopharmaceutical innovation (John LaMattina)

Medical innovation: How the US can retain its lead (Andrew Von Eschenbach)

