TCS Daily

A Better Way to Increase Access to Prescription Drugs

By Gregory Conko - February 8, 2007 12:00 AM

The new Congress spent much of its first month in office trying to increase patient access to costly prescription medicines. Their proposal would let the government try to bargain down prices paid for drugs by seniors enrolled in Medicare. But that fails to address what most doctors believe is a far bigger problem with pharmaceuticals: the extraordinarily high regulatory barriers to bringing new drugs to market.

In the wake of several high-profile drug safety scares - such as the withdrawal of the pain medication Vioxx in 2004 - bashing FDA has become second nature for many in Congress and the media. Although a panel of independent scientists advised FDA that Vioxx's benefits outweigh its risks, and told the agency that the drug should still be available, members of both parties have used the withdrawal as an opportunity to accuse the agency of recklessly speeding drugs to market for the sake of corporate profits at the expense of patients. But, according to the doctors who make up the front lines of mankind's battle against disease and disability, nothing could be further from the truth.

A poll of American doctors commissioned by the Competitive Enterprise Institute and released last week found that, far from thinking FDA is too quick to approve new medicines, three-fourths of doctors believe FDA is too slow. And 73 percent said that the "time it takes for the FDA to approve new drugs and medical devices hurts patients by forcing them to go without beneficial therapies."

The results were hardly surprising to those who have studied the drug approval process. This poll surveyed attitudes of orthopedic surgeons, but previous CEI polls - of cardiologists, oncologists, neurologists, and emergency room doctors - found similar results. A substantial majority of all these doctors believe that the slow pace of FDA reviews hurts patients more than it helps them. And it's easy to see why.

In each of the last two years, FDA's Center for Drugs approved just 20 new medicines with novel chemical compounds. That's down from a recent high of 53 in 1996 and 39 in 1997, despite a roughly 50 percent increase in new applications from 1993 to 2004. The length of time it takes FDA to review and approve new drug applications has also risen, from 13.4 months in 1998 to 23 months in 2005. And that's just the agency review, which comes after an average of eight or ten years of actual testing.

Of course, there are many reasons fewer new drugs are being approved, among which is the increasing difficulty of tackling harder and harder diseases. But that only accounts for part of the problem. Since the number of new drug applications submitted to FDA has grown considerably, it appears that the bigger problem is heightened political scrutiny of FDA and congressional demands for tougher reviews.

In the wake of Vioxx, politicians have increasingly complained that drug safety has deteriorated since the 1990s, when Congress passed legislation specifically intended to reduce the time it takes the agency to get new drugs to market. Initially, FDA did improve the pace of its reviews. But, the recent Vioxx episode shows why FDA has always been reluctant to implement genuine reforms.

If the agency approves a drug or device that later is found to be unsafe in any way, the public and politicians blame FDA for the error. But, if the agency delays when reviewing applications, the patients who need experimental new treatments are worse off, and some may even die waiting for FDA to act. In both cases, real people are hurt. But FDA is only criticized for approving risky medicines - never for keeping beneficial ones off the market. As the Vioxx episode shows so clearly, FDA faces huge incentives to slow the pace of its reviews.

As it turns out, however, that extra agency caution doesn't actually improve drug safety. Studies conducted by FDA itself show that the rate of drug withdrawals has remained essentially unchanged over the last 25 years, despite rising and falling approval times during that period. On the other hand, the health benefits of faster approval decisions far outweigh the risks associated with the small number of unsafe drugs that occasionally do make it to market.

One study by economists from the University of Chicago, MIT, Biogen Idec Inc., and Westfield Capital looked at all 662 drugs approved from 1979 to 2002 and concluded that, even if every withdrawn drug provided no benefits at all, the faster pace of approvals beginning in the 1990s benefited patients with an extra 180,000 to 310,000 years of life - roughly three to five times greater than the worst case estimate of harms.

Yet, even those drugs that are later withdrawn often prove beneficial to the vast majority of patients using them. The diabetes drug Rezulin, for example, is believed to have caused the tragic loss of 63 lives due to liver complications before it was pulled from the market. But 400 Americans die every day from complications of diabetes itself. So, FDA approved Rezulin, knowing that it raised the risk of liver toxicity, because its benefits to diabetics were so substantial. The agency decided it was better to warn doctors and patients of the risks, and allow them to weigh those risks against the potential benefits. FDA only asked the manufacturer to withdraw Rezulin after two new drugs in the same chemical class were shown to provide similar benefits with less risk.

While it was on the market, Rezulin offered substantial benefits to millions of diabetics. And, when FDA considered withdrawing the drug, doctors and patients pleaded with the agency to keep it available to them. University of California at San Diego medical professor Steven Edelman told the agency that the benefit to most diabetics using Rezulin was so great that, "You can't buy this drug back from these patients." Yet, even today, the Rezulin approval is viewed by FDA critics as a failure.

FDA is once again under enormous pressure to slow down reviews. But, since there is no way to rule out the possibility of even very serious side effects by testing a drug in a few thousand patients, the only way to ensure no withdrawals is to approve no new medicines. That, however, would be a real patient tragedy. Rather than forcing FDA to turn back the clock and slow down even further the approval of vital drugs, Congress should move forward, clearing away the regulatory barriers that keep beneficial treatments out of the hands of doctors and their patients.

Gregory Conko is a senior fellow at the Competitive Enterprise Institute in Washington, D.C.



Where is the author's solution?? How about a competing agency?
If you accept the author's premise (which I do) that the incentives for the FDA is to slow reviews due to them being mostly criticized for approving a risky medicine and not being criticized for not approving a potential beneficial medicine, where is the author's solution??

The author stating that "Congress should move forward, clearing away the regulatory barriers that keep beneficial treatments out of the hands of doctors and their patients" is not really a solution, cause Congress has the same incentives and disincentives as the FDA.

This might be a silly idea (increasing the bureacracy and all that), but how about a competing approval agency that primarily focuses on risk. A drug approved by this agency would officially be classified as "experimental" with ALL known and probable risks published and continually updated.

This way patients and their doctors could make informed decisions for what is best for THAT patient. The patient taking that approved "experimental" drug would have to sign a waiver not to sue if any adverse effects occur. If an adverse effect was known and NOT published, then the waiver would be void.

Drug companies could still get (the higher level?) FDA approval, but this would allow patients in need to get potential medicines faster without trying to achieve the Herculiean task of changing the mindset at the FDA.

A non-rush to Drugment
I think a competing "risk" agency would drive FDA approvals to zero. By definition all drugs with "risk" would be approved by the other agency and since all drugs carry risks the FDA would have nothing to do. Classing all drugs as experimental would drive up costs to consumers since many, if not most, insurance providers don't pay for experimental drugs.

The first thing we need to look at is how much of the 8-10 years of trials is really needed. How about 2 years of trials and 3 years of a phased implementation? One big problem with the trials is that you don't really have a large sample size and some of the side-effects may not be apparent until the drug is released into the marketplace. Some sort of phased implementation might help that BUT it may also increase the risk.

It's also not clear to me what the drug companies stand to gain by faster implementation. Sure, money *now* is more valuable than money *later* but if they can get a competing drug to market faster so can their competition. The drug companies will see a shorter period where they're the sole provider and may also see greater litigation expenses. The drug copiers might like the idea but the innovators would likely balk.

In the end it will boil down to how much risk consumers and their lawyers are willing to bear for the potential rewards of faster approval. In my experience, most people are willing to take risks if the result turns out OK but are unwilling to take risks when the outcome is bad. Sorta like the "if I knew then what I know now" line of reasoning.

Your idea might be better - at least another possible solution
My thought on a competing agency was just an attempt at some kind of solution other than hoping Congress will do something. Your idea is probably better.

I would say that anything that could lower the regulatory costs of drug implementation would be a net positive.

You are correct to note that unless some sort of acceptance of risk is considered by consumers and our court system, the situation will not improve. I'm talking about the acceptance of the KNOWN risk and taking your chances as an adult. If info is known and not shared, then the tort guns could come out.

buyer risk
i see this from a libertarian point of view.

the companies perform the research and provide the results of their studies. these results should be published and made available to the patients and their agents (doctors/ pharmacists).

promote freedom of choice. allow the patients to buy what ever medicines that they think will work for them.
allow the pharmaceutical companies to continue to seek the approval of the FDA. this seal of approval may be something that some risk averse patients will want.
those that are more aggressive should be allowed to acquire the experimental drugs.

what is not considered is the number of lives lost because the drug was disapproved or removed from the market.

why isn't there a class action suit against these lawyers!! their litigation is costing lives.

Good question on suing the lawyers
Remember the furor over silicone breast implants? The lawsuits that bankrupted Dow Corning? Silicone implants pulled from the market, new research confirms old research -> no health threat from the implants, silicone implants back on the market.

Speaking as a free market guy, the government should be doing everything it can to foster free, fair and open competition. The drug approval process in a very large impediment to competition and I'm not certain that the big drug companies mind the impediment overly much since they have the resources to overcome the obstacles.

While we don't want another Thalidomide disaster, we also don't want 1000's of people to die waiting for a drug that might have fatal side-effects for 50 people. It's a perverse, but understandable, situation. The 1000's that die before I release a drug can't sue for redress but those effected afterwards can, so the focus is on what might happen rather than on what is happening. And if I'm the FDA I know that the only deaths that will be reported are the 50 that occur following approval; what happens before approval is just "old news".

Somehow, I don't think the effort to find a Polio vaccine followed the same process. Wasn't that effort successful? Why can't we go back to the state of play in the 1950's? Or, at least compare the two different eras and build a system using the best of both. You know what I mean - do it like a private company would.

If you're not familiar with Thalidomide, try this URL:

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