Is the FDA Helping or Hurting Us When It Comes to New Medicines?

This press release is an announcement submitted by Pacific Research Institute, and was not written by Diabetes Health.

“...Lost in these headlines are the hundreds of thousands of people who lose their lives each year waiting for access to new life-saving or life-prolonging drugs that are mired in the FDA approval process.”

Apr 7, 2009

A new research report by the Pacific Research Institute (PRI) reviews three decades of the Food and Drug Administration's performance and concludes that the agency is over-funded, over-staffed, and denies hundreds of thousands of Americans timely access to new medicines. Leviathan's Drug Problem: The Federal Monopoly of Pharmaceutical Regulation and Its Deadly Cost was authored by John R. Graham, Director of Health Care Studies at PRI. 

President Barack Obama, in a radio address, asserted that "there are certain things that only government can do, and one of those things is...ensuring that the medicines we take are safe and don't cause us harm. That's the mission of our Food and Drug Administration." President Obama also claimed that the FDA is both underfunded and understaffed.

"In recent years, the contamination of American staples such as spinach, tomatoes, and peanut butter has made news headlines nationwide and has now captured the attention of President Obama," said Mr. Graham. "But lost in these headlines are the hundreds of thousands of people who lose their lives each year waiting for access to new life-saving or life-prolonging drugs that are mired in the FDA approval process. While food contamination is serious, the deaths resulting from long waits for new medicines far outnumber the lives lost from food contamination-indeed, Mr. Obama should move the slow FDA approval process to the top of his agenda." 

Overstaffed and Over-Funded

Many well-meaning observers continue to believe that the FDA's failures are due to a lack of funding and employees. "This is not the case," said Mr. Graham. Other developed countries have similar agencies that approve new medicines with far fewer employees. Great Britain's regulator is about one-third more productive than the FDA, and other European countries are even more productive. This is because the European Union has implemented a policy of regulatory competition, wherein a central regulator and national regulators compete for user fees that they charge manufacturers to lift their bans on new drugs. When one regulator has lifted its ban on a new medicine, all countries must generally reciprocate by lifting their bans.

The Prescription Drug User Fee Act, first passed in 1992 by Congress and renewed every five years, imposes a fee on drug manufacturers to fund the approval process. This excessive tax has dramatically increased the FDA's budget, so that half of the funds for reviewing new prescription drugs now come from this tax burden. Mr. Graham notes, "While this has sped up the FDA's bureaucratic processes somewhat, it has not transformed the harmful incentives facing the agency. Indeed, it has reinforced them and entrenched the FDA's monopoly power."

Leviathan's Drug Problem recommends that Congress amend the Food, Drug and Cosmetic Act to allow Americans to use new medicines after a regulator in a comparable jurisdiction, such as the European Union, has removed its prohibition. Drug makers would then be permitted, but not compelled, to distribute their medicines to willing doctors and patients in the United States. 

The report also recommends that Congress adopt the policy enshrined in the ACCESS Act, introduced by U.S. Senator Sam Brownback (R-Kan.) in 2008. This allows seriously ill patients who have exhausted other treatments to try experimental drugs at an earlier phase of regulatory approval than is possible now and encourages the FDA to use measures other than placebo trials to determine the safety and efficacy of such new drugs.

To download a copy of Leviathan's Drug Problem: The Federal Monopoly of Pharmaceutical Regulation and Its Deadly Cost, visit

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Categories: Food, Government & Policy, Medications, Professional Issues

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Posted by Anonymous on 14 April 2009

I agree that our FDA is in need of reform. As is the case with most government funded and operated programs, it does not work efficiently. One question I would ask, however, is this: If the process is sped up and medicines are released earlier, how will we prevent the potential litigation that will come with it from people who later say they were harmed by the medications and that more research should have been done prior to release to ensure safety(whether true or not). We seem to be a "sue happy" nation.

Posted by Anonymous on 14 April 2009

It would be useful to know the funding of this report because the conclusions are so contrary to current views, which generally note the lack of scrutiny for conflicts of interest by researchers, research reports truncated to be favorable to applications, and a host of other issues.

Posted by Anonymous on 14 April 2009

The FDA is "HELPING" us. Anyone who says otherwise is taking one too many medications. Pharmaceuticals are already using all of as guinea pigs while they are couunting the big bucks to see if their medications work.

Did you all see those commercials where a new pateneted drug has all those side effects? Basically they want you to be healthy when you take these "new" patented drugs.

Even Bonnie Hunt showed how ridiclous these commercials are. The name of the drug was not mentioned but I know that commerical where the man is walking to his mail box, and all the while it mentions the dangerous side effects this drug poses. Bonnie Hunt is not a doctor but she was a nurse.

I will say this again the only thing that will cure Type 1 Diabetes is Stem Cell research. Once researchers find the correct and safe form of treatment, and the FDA deems it safe that will be the only day I will get in line for treatment. As for the Pharmaceuticals like Eli-Lilly their days will be numbered. I will look so forward to that day when insulin will become obsolete, and it will be here soon. I would say in the next 5 or 6 years. According to Michael J. fox. On Oprah he mentioned stem cell research treatment will be here in 0 to 9 years.

Therefore this is no longer fiction this is fact!

Posted by Anonymous on 14 April 2009

Well if Michael J. Fox said it on Oprah it must be true!

I heard from an inside source that Michael J. Fox will be taking over the FDA, and Bonnie Hunt will be his wingman. I also heard that Clifford The Big Red Dog will run in the next presidential race... Stiff competition for Obama's re-election.

Posted by Anonymous on 23 April 2009

To the person who stated that "The FDA is helping" and that there will be a cure for Diabetes in the next "5 or 6 years" is either kidding himself or has no Idea how the FDA works. No, there will not be a cure for diabetes available anytime within the next decade. The key word there is "available" They may develop one using stem cell research or any method for that matter, but the fact is that due to the FDA's ill set regulations, every drug created takes an average of 8 years before it is ever available to the public. The whole point of this article is that it is way too long of a testing process.

A cure may be developed in the next 5 or 6 years, but we wont see it for almost a decade after its development.

The FDA is not helping.

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