Johnson & Johnson Is the Latest FDA Casualty

Does the Food and Drug Administration approve drugs anymore? Or are we seeing the lame-duck leadership at the agency punt any action over to the next administration?

Late Tuesday, the FDA gave Pfizer (PFE) full, formal approval of its new HIV/AIDS drug. But that was only to be followed by news out of Dow component Johnson & Johnson (JNJ) Wednesday morning that the agency can't approve JNJ's new drug for hospital-acquired infections just yet. In early trading, JNJ was the biggest dollar and percentage loser in the sector.

It's just the latest in a series of delays or rejections out of the FDA. The agency recently said an anesthesia-related drug from Schering Plough (SGP), already approved in Europe, can't be approved here. (The company says it will soon meet with the FDA to talk about turning things around.) At the company's R&D update meeting earlier this week, Schering-Plough Chairman and CEO Fred Hassan said he's looking forward to a changing of the guard at the FDA. The agency has twice delayed making a decision on whether to approve the bloodthinner Effient from Eli Lilly (LLY) after putting the pill under what's called "priority review."

That's designed to put potential new products on a fast track. So much for that. And, of course, the example—albeit an older one by now—certain biotech investors like to hold up whenever possible is Dendreon (DNDN). Despite an overwhelming recommendation from an FDA advisory committee to approve DNDN's prostate cancer drug Provenge, the agency refused to put the treatment on the market pending the outcome of another big clinical trial. And that's just to name a few.

In the agency's defense, it has been understaffed, underfunded and at times overwhelmed. Right now, for example, it's dealing with a new infant formula safety scare. The failings and fate of the FDA happen to be the subject of a nitty-gritty piece in today's "Washington Post."

While President-elect Obama is making economic-related cabinet and administration appointments his top priority, biopharma companies, investors and reporters like me are anxiously waiting to hear who he's going to pick to run the FDA. While it won't happen in time for Thanksgiving, someone who the industry and investors think would speed up the drug approval process while still watchdogging patient safety is something for which they would give thanks.

Comments

[cyclingscholar:]

How about an announcement like this:

The FDA is fundamentally a flawed organization, attempting to balance risk and reward for drugs when this is best left to doctors, patients, and their families.

Thus, from this point on FDA is to strictly an advisory agency. If they feel a drug is dangerous or ineffective, the sum total of their power shall be to issue the following proclamation:

"WE BEAN COUNTERS AND STATISTICIANS AT FDA HAVE TESTED THIS DRUG AND FOUND IT INEFFECTIVE AND POTENTIALLY DANGEROUS. USE IT AT YOUR OWN RISK, AFTER CONSULTATION WITH YOUR MEDICAL PROFESSIONAL."

cyclingscholar

2008 Nov 27 10:25 AM

[Frankie62:]

You may be right, cyclingscholor. FDA seems to have a cya attitude - not just for risk but also for the "consultant" doctors' piece of their pie. Many of them truly have conflicts of interest. Why would they approve a new drug or new treatment (see Provenge) which has virtually no side affects and extends life - their pharmaceutical company "consultant" ties might be negatively affected. But what patient in their right mind would choose miserable chemotherapy treatments if another less devastating immunotherapy is more effective. Let the patients decide, with their doctor's advice. And for goodness sake, separate the evaluation of headache treatments from the cancer and other life-saving treatments.

Frankie
On Nov 27 10:25 AM cyclingscholar wrote:

> How about an announcement like this:
>
> The FDA is fundamentally a flawed organization, attempting to balance
> risk and reward for drugs when this is best left to doctors, patients,
> and their families.
>
> Thus, from this point on FDA is to strictly an advisory agency. If
> they feel a drug is dangerous or ineffective, the sum total of their
> power shall be to issue the following proclamation:
>
> "WE BEAN COUNTERS AND STATISTICIANS AT FDA HAVE TESTED THIS DRUG
> AND FOUND IT INEFFECTIVE AND POTENTIALLY DANGEROUS. USE IT AT YOUR
> OWN RISK, AFTER CONSULTATION WITH YOUR MEDICAL PROFESSIONAL." <br/>
>
> cyclingscholar

2008 Nov 27 10:52 AM

[Frankie62:]

I agree with cyclingscholar. Allow the patients to decide, with the advice of their doctors. A new life-extending treatment should be allowed, especially when the FDA committee recognized it is effective and safe. FDA is becoming a cya organization - not just for patient risk, but for "consultant" doctor's risk to their bottom line ($$). Many in the FDA have true conflicts of interest - with ties to pharmaceutical companies payments. How could FDA have refused approval to Provenge, when it clearly was shown to extend life and have virtually no side affects? What terminal cancer patient would not choose a treatment with no side affects which may extend his life a few months, or years? Or would they choose to have devastating chemotherapy and be terribly ill for their remaining days? Let the patients decide for themselves - it's their life or death. Whatever happened to "First do no harm"?

2008 Nov 27 11:04 AM

[in4thelonghaul:]

Thanks Mike for your efforts...

A sad indictment of American society that a small group of beaurocrats have achieved such a level of power as to actually dictate matters of life and death by denying potentially life-extending treatments to the terminally ill on the absurd pretext that such are not fully proven effective and might possibly be harmful!! Matters are worse by magnitudes thanks to the captured regulators of congress who have wholly abdigated their lawful role of oversight, as the American 'sheeple' silently accept the outrageous with barely a peep of protest by the vast majority of mainstream media or the courts of last resort.

Americans have been slowly boiled...inculcated and brainwashed to the point that they will tolerate quietly almost any outrage; to think our forefathers resorted violent revolution on a pretext so much more mundane than what we routinely accept with the most pathetic whimpers.

With luck, Obama will appoint an FDA Commissioner with sufficient humanity, integrity, insight, and will, to thoroughly sweep out the institutionalized filth which has found such a comfortable abode at the upper echelons of the FDA; we will know soon enough.

2008 Nov 27 11:21 AM

[inhumane fda:]

THE NEXT FDA COMMISSIONER

It’s the Citizens that the currently unfriendly FDA are there to serve, a fact long forgotten by the current FDA. Also, TIMELY access to innovative new treatments for patients with late stage disease where there are no good alternative treatments available which was important enough to encompass within the revised FDA mission statement must be a priority. That mission was not accomplished under our current FDA chief.

The next FDA commissioner needs to remember the mission of the FDA is to protect and serve the Citizens and to speed innovative safer new treatments to them. The next commissioner should stop ignoring the pleas of the citizens! In the current FDA the Citizens have no voice and nobody at the top levels of the FDA has shown any inclination towards be caring or sensitive to patient rights.

Currently, Citizens do not have a voice in the FDA. The Citizen Petition process at the FDA is broken, as the FDA is completely unresponsive to filed Petitions. The FDA’s consideration of the opinions of patient advocates and even their own hired expert’s opinions at AC hearings are given mere lip service.

The public is given no rights, no voice and no way to express its concerns to the Agency. There is very little support left for the agency in its current decayed state. Even the staunchest of supporters such as Peter Barton Hutt, former FDA Counsel, who went before the Energy and Commerce Committee in January 2008 to ask for more funds for the agency, when current commissioner Andrew von Eschenbach would not do so as he was afraid to anger/upstage President Bush, now admits that the agency is broken. “This is a fundamentally broken agency,” Hutt stated earlier this year, “and it needs to be repaired.” Mr. Hutt has laid out some basic principles for sound government regulatory policy. They are:

1. To protect the public from harm.
2. To preserve maximum individual freedom of choice.
3. To guarantee meaningful public participation in the decision making process.
4. To promote consistent and dependable rules that are equally applicable to everyone.
5. To provide prompt decisions on all of the issues that arises in a regulatory context.

Quoting Mr. Hutt: “The third principle is an easy one-public participation. Our country was founded on the democratic principle of participation.
During the early years of government regulation this was not a central
issue because the government was not regulating very much, its
intrusiveness was not very noticeable, and therefore participation was
not sought after. But as regulation has grown and real restrictions have
affected all of us, public participation has become essential to
legitimizing the regulatory process. In my opinion, the most important
statutes Congress has enacted in the past 100 years are the Freedom of
Information Act, the Sunshine Act, and the Advisory Committee Act”.

Currently, the FDA ignores the public to the point that it is seemingly annoyed that the public dare even bother them, has made a mockery of the Advisory Committee Act, is unresponsive to Freedom of Information Act requests and has absolutely no transparency or accountability. Nobody knows how a decision to approve or deny a license is even made.

All of this is easily demonstrated by a review of the case of Provenge. In the case of Provenge, an immunotherapy for late stage prostate cancer patients, the FDA ignored its own expert advisory committee and patient advocates at the AC hearing, refuses to decide a Citizen Petition regarding Provenge filed in July 2007, has ignored a FOIA request to CDER to produce documents relative to the matter and has ignored advocates calls for approval, despite an October 2008 Independent Data Monitoring Company (IDMC) report showing increased survival and no safety concerns for Provenge.

The next FDA Commissioner needs to be someone who can understand the principles of regulatory government, be someone who knows who he works for, and one who will strive for a more transparent, accountable and citizen friendly agency.

Note: Provenge was once not approved because it missed on an endpoint of Time to Progression (TTP) by two one thousands of one percent, even though it showed survival, because survival was not the pre designated primary endpoint. Since then an IDMC said that Provenge again showed survival advantage and was safe but it was only 20% survival and not the 22% commanded by the FDA at an interim study peek. Despite a January 2008 letter from Jesse Goodman indicating that the agency was actively considering the petition to reconsider Provenge approval, the agency has since been unresponsive despite the additional evidence as recently reported by the IDMC.

2008 Nov 27 12:00 PM

[huangthomas:]

We can't leave the issues of drug effectiveness to the decisions between physicians and patients. Physicians' interest is more closely tied to drug companies. They play a dominant role in the decision making. The patients will be the eventual losers.

2008 Nov 27 07:35 PM

[inhumane fda:]

Huang Thomas. While some oversight might be needed do you want Richard Pazdur at the FDA making the decision if you have no viable treatment options?

The FDA admittedly does not know how to properly evaluate innovative new treatments. Worse still they ignore their exper AC panels who do know how to do it.

Nobody at the top of this FDA has any humanity and nobody cares enough to do a proper risk/benefit analysis that properly reflects the risks to late stage prostate cancer patients.

That is why the FDA must listen more to advocates, less to big pharma and timely decide citizen petitions (not to mention respond to FOIA requests). The FDA works for us not big pharma. Litttle biotechs like Dendreon are threats to them, especially when they refuse to sell out to them.

Provenge wil be approved in 2010 but it is those that are missing out now that are the current victims of the inhumane FDA.

2008 Nov 28 09:02 AM