The Situation at the FDA: We Are All to Blame


Xconomy San Francisco — 

[Editor’s Note: We asked selected Xconomists a series of questions designed to zero in on the big issues of the year, including “What would you be willing to throw a punch over?”]

It takes a lot to get me riled-up—I’m overly rational, if anything. Outside of the bad behavior we were supposed to outgrow in kindergarten—dishonesty, disrespect, etc.—there are few professional issues of sufficient emotional magnitude. One of the most frustrating issues today is the FDA situation. While easy to say, “The FDA is at fault and needs to be reformed in order to speed the approval of new medicines,” that is a dramatic oversimplification of the problem. All parties in the ecosystem are at fault to some extent, and it will take concerted efforts and change by each in order to fix it.

For example, the FDA has absolutely been more/overly safety conscious in recent years, but I believe we all would act that way if faced with being hauled in front of Congress to justify the risk-benefit of a drug approval that positively impacts more than 99.99 percent  of the people who use it. Why should we, as a country, require or expect that medicines be as safe as clean water? At the core, sick people, whether with cardiovascular issues, autoimmune disease, or other afflictions, are taking a medicine in order to improve their condition, so while absolutely safe drugs would be wonderful, a level of risk is warranted based on the improvement in the disease. If we can cross that bridge and accept that medicines will have risks, then we have the tools to deal with the safety vs. speed of approval conundrum. We can shorten commercialization timelines while dramatically improving safety monitoring if we test for efficacy and major safety during development, while tracking long-tail safety issues in the commercial setting—perhaps the first 100,000 people prescribed a new product?

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2 responses to “The Situation at the FDA: We Are All to Blame”

  1. Vern Dahl says:

    One of the problems faced by FDA is reviewers are in a no-win sutuation. If they approve 100 drugs/devices and all perform as expected, no one says “thank you FDA”. However if after approval number 101 is found to be defective, becomes the subject of a recall, is pulled from the market or god forbid harms .001% of the patients we read about it on page one of the New York Times, see massive television advertising from lawyers looking for clients and the FDA is brought before Congress with new laws proposed to “protect us”.

    I am not making excuses for ANOTHER sluggish government agency and am embaraced (as a US citizen) to see, as just one example, the transcatheter aortic valve available in 51 countries for 4 years before the first (limitted) FDA approval. Yes the FDA “protected” us for several years from the small possibility of valve failure but at what cost? How many patients were denied heart valves and DIED waiting for the FDA.

    Drugs/devices will never be perfict but neither will the disease process. We are flooded with information and statistics on product performance, perhaps a new statistic that should be generated is the number of patients denied lifesaving drugs/devices that die waiting for the FDA.

  2. Gamma Therapeutics, an Oregon venture start-up, visited the FDA OIVD office in September to introduce our new non-invasive cardiac biomarker diagnostic test, GammaCoeur, to receive guidance regarding BETA testing. The analyte in the GammaCoeur CVD Risk Assay was strongly correlated in a host of independent studies including the premier study of cardiovascular disease (CVD),coronary heart disease (CHD) and related stroke studies, carried out by the globally recognized Framingham Heart Study. The banked blood samples are accessible by request and have been used in thousands of tests of biomarkers and new CD drugs. However, the definition of MI has changed since 2003 and so the samples are no longer useful, according to the FDA, as a means to test the GammaCoeur analyte and correlate it with cardiac risk. The FDA’s suggestion for a non-invasive blood test identical to predicate tests already on the market; start a new test series with new patient samples and look at it over several years to correlate CVD risk. So, instead of a non-invasive test that should easily clear in six months, it may take years for it to come to market and may result in additional deaths among at risk cardiac patients, as worst case scenario, and prevent the availability of a diagnostic test that can guide physicians to design better and more successful preventive medicine care, eliminate expensive and long term drug regimens and preclude the need for invasive cardiac surgery. It is this reason that the FDA needs to be “re-engineered” for a new era of medicine.