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FDA's 'Critical Path' to restore industry's confidence

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FDA’s ‘Critical Path’ to restore industry’s confidence

Take a look inside your bathroom cabinet. Chances are you’ll find old, generic medicines in it that you rely on everyday, like aspirin, that wouldn’t gain FDA approval today because of rare side effects. In the case of aspirin, those side effects include potentially fatal stomach bleeding. Drugs today face higher regulatory burdens than ever before but, ironically, public confidence in the FDA and industry seems to have sunk to new lows.

President Bush’s 2007 budget will help reverse that trend. It contains funding for the FDA’s "Critical Path" initiative that will help the agency and its stakeholders develop better tools for measuring the safety and efficacy of new medicines. These tools will also improve confidence in FDA-approved medicines and lower the costs of drug development.

Does this mean that older medicines are unsafe — or that the companies that market them are irresponsible? Not at all. It is, however, true that new medicines face a very different political and regulatory environment than their predecessors. Today, even minor risks from prescription drugs and vaccines are seen as increasingly unacceptable. At the same time, drugmakers spend ever more time and money trying to meet FDA standards for drug approval, while wondering when a new safety scandal might raise the bar yet again.

Prescription drugs are a victim of their own success. As Americans gain access to new medicines that treat once untreatable illnesses, the public’s attention has shifted from the risks of the disease to the risks of the drugs.

Critics who allege that the FDA is a shill for industry ought to take a good look at the time and costs required to bring a single new drug to market. Since 1962, when the anti-nausea drug thalidomide made headlines after causing thousands of birth defects in Europe and Japan, U.S. policymakers and regulators have become increasingly sensitive to adverse drug events and piled new regulations on drug companies.

In order to navigate FDA safety and efficacy hurdles imposed in the wake of the thalidomide tragedy, pharmaceutical companies often spend over a decade and hundreds of millions of dollars shepherding a single new medicine to market. Only about 1 in every 5,000 company-tested compounds ever achieve FDA approval, and that single drug must recoup the costs of every other failed project and generate handsome profits to boot. If industry was looking for a rubber stamp regulator, they certainly wouldn’t choose the FDA.

Still, even after this rigorous and time-consuming process, nasty surprises can still crop up after a drug is approved for public sale. The problem with drug safety, to paraphrase Hamlet, lies not in the stars but in ourselves. The tools companies and the FDA use today to evaluate new drug candidates cannot anticipate every rare side effect. Human DNA is just too diverse to allow companies or regulators to make blanket predictions about drug safety.
Without better tools that can identify safety problems earlier in drug development, companies and regulators will continue to be shadowed by media headlines trumpeting drug safety "failures" that lead to deaths and hospitalizations.

Take the case of the painkiller Bromfenac, withdrawn from market in 1998. The FDA pulled the drug after it had been on the market for about a year when postmarket surveillance uncovered that the drug caused serious liver damage in about "1 in 20,000 patients taking the drug for longer than 10 days." The FDA notes on its web site that "to reliably detect the toxic effects of a drug with a 1 in 20,000 adverse drug reaction frequency, the new drug application database would have to include 100,000 patient exposures."

Forcing drug companies to routinely run trials with 100,000 patients each would bring the drug discovery process to a screeching halt. We should also keep in mind that many drugs initially vilified by the media and FDA critics — Vioxx, Lotronex and thalidomide, to name just a few — have important and legitimate uses for many patients. Thalidomide, for instance, is now routinely used to treat some cancers. Many arthritis patients swear that Vioxx was the only drug that gave them relief from crippling pain.

Our public intolerance for risk, amplified by a media and plaintiff’s bar eager to demonize drug companies, is doing more harm than any "risky drugs" by denying access to new medicines. This is why the FDA’s Critical Path initiative is so important.

The holy grail of drug discovery is being able to identify early-on in drug development which drugs are likely to cause side effects in certain groups of patients, and then either killing those drugs or using genetic or diagnostic tests to screen patients postmarket. The Critical Path project will help the FDA and industry develop some of these vital predictive tools.

The President is proposing modest funding for the program to start off with ($6 million), but FDA’s effort to learn more about the relative risks of drugs for specific patient groups is a gateway to a world where patients know that drug safety hinges on better science keyed to their own DNA. As this happens, FDA and industry bashing should fade even as FDA regulations become more streamlined and cost-effective.

The alternative is to continue on the path we’re on now, where the costs and time required to produce new medicines expands year after year in a futile quest for perfect safety. After all, the only safe medicine is no medicine at all.

Written By

Mr. Howard is the managing editor at MedicalProgressToday.com.

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