Envisioning 2.0

This article is part of an ongoing series on this blog titled: “The FDA and the Pharmaceutical Industry.” Click here to read other posts in this series.

The Food and Drug Administration (FDA) is currently a very bruised, battered and bewildered agency. A recent Harris Interactive/Wall Street Journal poll indicates that the public is loosing confidence that the FDA has the ability to ensure the safety and efficacy of prescription medications. Consumer advocates are saying that the FDA is doing too little to remove unapproved drugs from the market. To make matters worse, the agency is facing increased scrutiny over how it handled a recently halted clinical trial testing the antibiotic Ketek in children. (At issue is the appropriateness of using non-inferiority rather than placebo-controlled clinical trials to approve antibiotics. For more on this topic, see this post.)

The FDA is not without its defenders. Robert Goldberg, PhD of the Center For Medicine in the Public Interest and co-author of the blog Drug Wonks, has regularly taken critics of the FDA to task on a range of issues, including clinical trial design and drug safety. (See this recent post on Senate Finance Committee Chairman Chuck Grassley’s oversight of the agency.)

So, is the FDA a paper tiger, or an overzealous regulator? Let’s take a look at both sides of the issue.

The FDA As Overzealous Regulator: The FDA’s Drug Approval Process

According to researchers at Tufts University, drug makers spend an average of $802 million to develop a new medication. A decision by the FDA can determine whether a company recoups its investment. In the 1980s, critics assailed the FDA for taking too long to approve new medications. In response, Congress passed the Prescription Drug User Fee Act in 1992. Under this legislation, drug makers are required to pay a fee to the FDA to defray the costs of approving new medications.

Some critics of the FDA feel that it does not use its power to approve or deny medications appropriately. One prominent example is the debate over the “Morning After Pill.” Women’s health advocates wonder why the agency has not approved the medication for over-the-counter use. What is driving the FDA’s decision-making: politics or science?

The FDA As Paper Tiger: Drug Safety

The withdrawal of Vioxx and other medications from the market sparked a firestorm of criticism of the FDA. Did the agency do enough to ensure that these medications were safe and effective? What is the agency doing to track drug side effects post-approval?

The FDA responded to critics by announcing plans to form an independent board to oversee the agency’s handling of drug safety issues in 2005. However, some have said that the board is not effective, partly because it holds closed-door meetings. In a February 2006 analysis published in Newsday, Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said that closed meetings are “not good public policy.” In the same article, FDA drug reviewer David Graham asserted that the board was another example of “one of several deceptive moves by FDA management to try to convince Congress that it’s capable of reforming itself.”

The FDA As Overzealous Regulator: Let The People Decide

Some patient advocates with rare (orphan) diseases and certain types of cancer, such as Multiple myeloma, which affects 63,000 people per year, have wondered why the FDA is so slow to allow them to take experimental medications. In certain cases, the FDA will approve the use of unapproved medications outside of clinical trials. However, securing permission is difficult.

Despite the dangers associated with taking experimental medications, some patients and their caregivers are willing to take the risk. For many of these individuals, the FDA can never act fast enough to approve a medication. They want the FDA to step aside and “let the people decide.”

The FDA As Paper Tiger: The FDA’s Inspection Of The Tissue Industry

Early last week, an Associated Press (AP) article stated that “a piece of fruit coming into the United States is more likely to get government attention than a ligament or heart valve taken from a cadaver and destined for transplant.”

According to the AP, the FDA’s inspection of companies that sell tissue has sharply declined. Inspections have sometimes come too late to prevent tainted tissue from entering the marketplace and being implanted into patients. Patient advocates are dubbing the issue of the FDA’s lax oversight of tissue companies a “crisis.”

My View

As we have seen, issues involving drug safety, drug approval, inspections and orphan or rare diseases are highly complex. However, the question remains: is the FDA a paper tiger or an overzealous regulator?

The truth is that the FDA is somewhere in the middle. At times, it has acted too quickly to approve a medication or clinical trial. In other instances, it has been much too conservative. What we must remember is that the FDA has – and will continue to – make mistakes. What matters is what the agency is doing about them.

One FDA staffer I spoke with recently put it best by saying:

“You have to remember that there is no ‘The FDA.’ The FDA is made up of [thousands of people] from the commissioner to the janitor. There is no one brain that [manages the whole enterprise]. There are many people who are trying to do the right thing. [People on] both sides need to say: We’ve made mistakes and . . . we need to do better.”

Now, that’s good advice.

Next Up

Antibiotic Resistance, Clinical Trial Development and the FDA:
An Interview With John Powers, MD

This entry was posted on June 13, 2006 at 12:39 pm and is filed under FDA and the Pharmaceutical Industry, Health Policy, The Pharmaceutical Industry. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.