The Problem with Fast-Tracking Drug Approvals: Pharmas Fail to Follow Up

To get potentially lifesaving drugs to patients faster, the U.S. Food and Drug Administration is allowed to approve some drugs -- those that address unmet medical needs -- based on fewer trials than usual. But an advisory panel on Tuesday recommended that the FDA demand more from pharmaceutical companies that request expedited approvals for cancer drugs, both before -- and certainly after -- the approval.

Companies that get accelerated approval don't have to meet the FDA requirement of two randomized trials to show that a drug is safe and effective. But the companies are then supposed to complete additional post-marketing studies to verify the drug is as safe and effective as the initial results indicated.

A Poor Record of Following Up

It turns out that many of the companies have been slack on following through with their post-marketing commitments. Out of the 49 accelerated approvals for cancer drugs -- 29 of which were approved based on a single trial with no control arm to verify improvement -- only 55% have completed post-marketing studies verifying benefit, Nature reports, while 10.2% failed in post-marketing studies. Others have yet to conduct the trials.

Five of the drugs haven't completed the required testing more than five years after receiving their accelerated approval. If these are eventually found to be ineffective therapies, they'll already have been on the market for far too long benefiting only companies' coffers.

The fast-track drug-approval process recently came into public attention when the FDA revoked the breast-cancer approval for Roche's blockbuster drug Avastin, which had been fast-tracked. While many were outraged by the FDA's decision, the regulatory body said that follow-up studies on Avastin failed to prove the drug works for breast cancer.

But at least Roche performed the study. On Tuesday, members of the Oncologic Drugs Advisory Committee grilled representatives of Eli Lilly (LLY), GlaxoSmithKline (GSK), Genzyme (GENZ), Amgen (AMGN) and Novartis (NVS) about their failure to complete such trials for six drugs.

The companies said that, despite trying to complete the follow-up studies, they couldn't find enough patients to generate reliable results. The FDA has also agreed that some trials promised by companies couldn't be performed because they became outdated.

Where Are the Teeth?

The FDA actually has the authority to fine a company or to revoke a drug's approval if the manufacturer fails to meet its commitments. But no such threats were made at Tuesday's meeting, according to MedPage Today. And without them, it's unclear what, if any, incentive drug companies have to actually follow through with their obligations. If anything, from the Avastin example, they may have incentive not to do so.

In Europe, The Wall Street Journal notes, a similar program grants approval for just one year, and the approval can then be renewed if the companies are making progress in meeting their post-marketing commitments.

Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products, suggests holding review meetings once a year. FDA advisers also discussed the possibility of tightening requirements for accelerated approval and requiring companies to begin confirmatory clinical trials before receiving approval.

Of course, there's also a downside to these types of changes: They might delay the approval process of these potentially lifesaving drugs.

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February 11 2011 at 2:08 PM Report abuse rate up rate down Reply

The headline should be: The Problem with FDA Drug Approvals: FDA Fails Us & So Do Writers Covering It

"Of course, there's also a downside to these types of changes: They might delay the approval process of these potentially lifesaving drugs."

Ya think so, Melly?

You have got to be kidding me with this article. There are so many discoveries out there that cannot come to market, principally due to the amount of money it takes to satisfy FDA standards, requirements and other demands along the way. People who are terminally ill die while the FDA worries about the same people taking drugs that might not be as effective as intended or even harmful, or that drug companies might (heaven forfend) make money after taking great risks and expending much capital trying to help such people?! So I guess a certain death for Americans is a much better and safer option for the FDA.

And to top it off, your article expresses worry about follow-up studies not being done and submitted to the FDA, while people are dropping dead because research and discoveries can't be translated into life-saving measures, overwhelmingly due to the economics. Get out from behind the desk Melly, and talk with folks outside of the FDA and Big Pharma, such as those who have been affected by the egregious (and worsening) delays inherent in the FDA process. They are legion.

February 11 2011 at 9:07 AM Report abuse rate up rate down Reply
1 reply to ginalovebug's comment

First, the drug companies have PLENTY of money to afford the proper testing. Secondly, there is no reason they cannot fullfill the testing after their product has been fast-tracked. Yes some people with "nothing to lose" might benefit from some of these drugs, but they might also benefit from the next drug that has been thoroughly tested. You're not an attorney are you?

February 11 2011 at 7:01 PM Report abuse +1 rate up rate down Reply

My Father has Myelodysplastic Syndrome, which is terminal.... preleukemia, abnormal chromosomes production. Mt. Sinia, Dr. Silverman, has a medicine in trial, Vorinostat, which is successful with "other" cancers. Because it is NOT approved for MDS, it has to go to trial. My father's labs were critically low, 14,000 PLT, 8.0 HCT, blood transfusions ect. The Docs at Mt. Sinai said they were seeing great success with the Vidazia and Vorinostat combination. My father's lab came back absolutely normal yesterday!!! These patient's are terminal! Why does the FDA require 150 patients and a 3 phase trial to approve, which will take years? Each week, we drive 7 hours to obtain the drugs, due to the trial. We can't get the drug local because it is in TRIAL. Does this make sense to anyone? With out it, his expectancy was 12 - 18 months. Too Much Government!

February 11 2011 at 5:32 AM Report abuse +1 rate up rate down Reply

Let me ask? With street drugs poured on the world's population in vats, ask the drug dealers, did your customers die? No, we'll push it on the public. Ask Ashton Kutcher, didn't he go to college to "make anything?" Pharmapseudical companies are legalized drug pushers with a captive audience. Face it, the Black Market royals have become fed up with the red tape bullshit, just let us sell our drugs. If any one of those bastards really cared, drugs would be legal and not pushed or prescribed. Cancer is unfortuantely BIG BUSINESS, it is not in their best interest to 'figure it out' or god forbid, CURE. The industry is a failure.

February 11 2011 at 4:49 AM Report abuse -1 rate up rate down Reply

Yeah...and the delay might save the lives of millions that will have a fatal side effect or keep them from moving on to a drug that actually works!

February 11 2011 at 2:33 AM Report abuse +2 rate up rate down Reply
1 reply to James's comment

AOL censors comments. They will not post my comments reguardless of content. AOL refuses to even reply to any feedback. Nice ISP

February 11 2011 at 3:45 AM Report abuse rate up rate down Reply


Did the drug,neurotin, cause any type of tumors and/or tumor growth, in any of the tests or studies of the side effects of this med in lab animals,prior to being released for maketing for Human consumption and treatment for chronic or severe neurological pain?


February 11 2011 at 2:12 AM Report abuse rate up rate down Reply

First of all, this article is lame and doesn't even come close to covering the story -- the Reader's Digest of AOL News! It is not the FDA -- they are highly qualified and in my experience, highly ethical when it comes to cancer drug trials and safety. Believe me, cancer patients push hard for early release of any drug that they think might help them, without waiting for the results of conclusive clinical trials through phase III.

I work in cancer research, protecting human subjects, and it is my job to see that people are aware of the risks and benefits of experimental drugs or treatments. When you have stage IV colon cancer and there is a chance you might extend your life by a few months or a year, many will take the chance. On a clinical trial, you have to accept the risks to participate through a federally regulated informed consent process. With expanded early access, you don't care if it has been proven effective, you just want the drug (and think you deserve it) and then you want to sue because it made you sick. Keep in mind, the costs of running clinical trials and getting a drug from lab to pharmacy are staggering. Right now, some of this money is made back by success drugs like Viagra, prozac, etc. Remember though, newer drugs (not for cancer) need only be shown to be "as good as" an existing drug, but they often have unknown risks. You're always better off with older, legacy drugs. (this excludes cancer drugs, though many of the new promising ones, like bevacizumab/Avastin, do have life-threatening side-effects and often relatively small amounts of success).

And the best way to keep your health and avoid all this? It's no secret: Lose weight (diabetes, kidney failure), exercise (heart disease), eat right (hypertension), get preventive care (colon, breast cancer) and don't smoke (cancer). That'll solve our country's health care AND economic problems! That the richest country on earth is the most gluttonous and unhealthy, with so many suffering from illness caused by their own bad habits, but can't afford to give it's poor McDonald's-eating citizens dialysis, is a real shame, but not a surprise.

February 11 2011 at 2:08 AM Report abuse +2 rate up rate down Reply

The FDA is simply an incredibly weak organization with strong financial ties to the pharmaceutical companies. It's fairly worthless when it comes to protecting the American people.

European countries, while certainly not powerful in their control of the pharmaceutical industry, are frequently far more stringest in their controls and requirements than the FDA. Is used to be we, as Americans, could pride ourselves is the way our government protected us from bad drugs and pharmaceutical greed. But, no more. The watchdog called the FDA is trained, walked and fed by the very industry it is supposed to be watching.

Too bad it's the American people who suffer while ex-FDA officials get jobs with the pharmaceutical firms.

February 11 2011 at 2:04 AM Report abuse +2 rate up rate down Reply

Big Pharma needs a buffer between them and the public. It is all about profits, not people. They already own the nightly TV news and their insidious commercials flood the airwaves and the magazine racks. Hell, there is even a drug now that will grow eyelashes! When does it stop? Many of these preparations are too harmful and have too many side effects to be beneficial to humans. Look at Abilify, Plavix, Lyrica... designer names and logos and each has a long list of side effects. They even want to addict your pets! Enough already. You have to ability to maintain your health in your own two hands: sensible eating, regular exercise, moderation in all things.

February 11 2011 at 1:09 AM Report abuse +2 rate up rate down Reply

If I'm in a life-threatening situation where a new drug may help me, I'm going to take it, and to hell with the FDA.

February 11 2011 at 12:22 AM Report abuse +1 rate up rate down Reply
1 reply to JC's comment
Hello Butch

Your case is different and in your case you should be able to buy the drug, as long as you know it may make things worse.

February 11 2011 at 12:40 AM Report abuse +2 rate up rate down Reply