FDA approval process

Drug Approvals Set to Surpass 2010

Before drugs show up on store shelves in the U.S., they go through a lengthy approval process. This process ensures that proposed drugs produce the results they claim and all potential side effects are known and well documented. But most importantly, the process attempts to assure that every new drug is safe for human consumption.

The process, which many in the pharmaceutical industry claim has become cumbersome and expensive, was created and is enforced by the U.S. Food and Drug Administration. Once approved, every new drug gets to wear that all-important “FDA-approved” stamp on its packaging.

The number of new drug applications submitted each year keeps FDA staff and drug manufacturers extremely busy. For all their hard work though, not all of the new drug applications submitted each year make it all the way through the approval process.

To date, the FDA has approved 20 new drugs this year. This figure is very close to surpassing the total number of drugs approved by the FDA in all of 2010 which was only 21. To clarify, this figure includes approval of new drugs and biologics but does not include applications for reformulations or expanded uses of already approved drugs and vaccines.

The higher drug approval rate is a welcome increase over previous years that should appease those who claim that rigorous safety requirements have led to higher manufacturing costs, longer approval processes and less investment in U.S. companies that make up the life sciences industry.

Among the new drugs approved so far in 2011 are:

• A drug for hepatitis C developed by Merck & Co.
• Another drug for hepatitis C developed by Vertex Pharmaceuticals, Inc.
• Yervoy, a drug to treat melanoma developed by Bristol-Meyers Squibb Co.
• Benlysta for lupus from GlaxoSmithKline PLC and Human Genome Sciences Inc.
• A drug designed to prevent blood clots called Xarelto by co-developers Bayer AG and Johnson & Johnson.

There are others, and likely will be more approved by year’s end. But there will probably be a number of drugs that do not make it through the process, as well. For one reason or another, a lot experimental drugs never make it past the various trial phases. Although discouraging for people who invest a lot of capital and time into their development, such failures really should not be blamed on the FDA. The agency is simply doing its job and trying hard to avoid a repeat of what happened with popular painkiller Vioxx, which ultimately was withdrawn from the market after receiving approval.

Janet Woodcock who leads the drug division at the FDA makes no apologies for the current process. She points to the agency’s high drug approval rate during the six to ten month period after application submission and notable track record for meeting deadlines. It’s true that requests for additional information can delay the process or lead to a drug’s failure. But in my opinion, this is one situation in which it is better to be safe than sorry!

What do you think?