Prescription Drug User Fee Act

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Who’s to Blame for Dangerous Prescription Drugs: The FDA or Big Pharma?

in Healthcare, Liberator Online Archives, Libertarian Answers on Issues, Libertarian Stances on Issues by Mary Ruwart Comments are off

(From the Ask Dr. Ruwart section in Volume 19, No. 10 of the Liberator Online. Subscribe here!)

QUESTION: The pharmaceutical company is sometimes caught pressuring the FDA to approve drugs with dangerous prescription drugsside effects and the FDA does so. Who is the prime mover of aggression here, the FDA or the pharmaceutical cartel?

MY SHORT ANSWER: It’s the karmic circle. The American public allowed the FDA to regulate the pharmaceutical companies under the largely erroneous assumption that they were nefarious. In the beginning, the primary loss to the American public was fewer life-saving drugs, since more money had to be spent on development instead of discovering new drugs.

The regulations reshaped the industry in a way that encouraged graft, as the regulations got more onerous. The industry “fought back” with the Prescription Drug User Fee Act which lets companies pay about $1 million for a faster review. This co-opted the regulators, since about half of their budget now comes from such fees.

In addition to losing many life-saving drugs, the drugs that we get now are less safe. The biggest safety problem with drugs on the market today is that they are meant for long-term use, which amplifies side effects. That’s because only drugs for long-term use can recover the high cost of development that regulations have produced. Even with the high prices of drugs, only 3/10 recover their costs.

This is a lose-lose situation for the American public, the industry itself (which has become close to unsustainable), and even the regulators, who will one day die or watch their loved ones die from diseases that might have been cured without regulations.

LEARN MORE: Suggested additional reading on this topic from Liberator Online editor James W. Harris:

* “Abolishing the FDA: FDA Policies Keep People Sick and Create a False Sense of Security“ by Larry Van Heerden The Freeman, March 1, 2007.

Excerpt: “The Food and Drug Administration (FDA) started out as a bulwark against snake-oil peddling. It has since swung back and forth between hostility and subservience to the drug industry. The FDA seems indifferent to the many deaths its own intransigence has caused and imperious when forced to defend its actions in court, resulting in a system that withholds life-saving drugs from the market, approves dangerous drugs, and denies everyone freedom of choice. The time has come to seriously consider abolishing the FDA.”

The FDA Vs. the Health and Safety of Americans

in Communicating Liberty, Healthcare, Liberator Online Archives by Mary Ruwart Comments are off

QUESTION: Which problem is the greatest: the FDA’s approving unsafe drugs, or the FDA’s delaying the approval of life-saving ones?

MY SHORT ANSWER: In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), allowing drug companies to voluntarily pay about $100,000 to get a speedier review. The money went to hire new reviewers.

The fee has grown steadily; it’s now over one million dollars per drug. The part of the FDA that reviews drug applications now receives about 50% of its funding from drug companies. FDA employees (e.g., Dr. David Graham, the whistleblower on Vioxx) have reported being told by supervisors that the drug companies — not the American public — are the FDA’s clients. This should be expected, as he who pays the bills makes the rules.

Does this mean that the FDA now approves unsafe drugs? It depends on how you look at it. Withdrawal rates (the percent of approved drugs removed from the market) from 1962-1992 and 1993-2013 are virtually identical at about 3%. As time goes on, however, more drugs approved during 1993-2013 are likely to be withdrawn. The differences may be small, though, as most withdrawals occur quickly. On the other hand, Vioxx, approved post-PDUFA, was by far the biggest drug disaster in history.

Does the FDA still delay approval of life-saving drugs? Yes! It does so by demanding that companies perform studies taking an average of 13-plus years. Prior to 1962, the average time was about 4 years. I suspect that these delays are still more costly, in terms of lives lost, than approvals of unsafe drugs.

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