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The FDA Steps In: Regulating Prescription Drug Promotion on the Internet

KATE GREENWOODKate-greenwood-7-16-08-compressed-200x300

The FDA has been widely criticized for not providing guidance for drug companies eager to promote their products on the internet.  Earlier this year, the FDA expressed the view that the message was what was important, not the medium, meaning that companies should simply apply the rules governing prescription drug advertising in print media to the internet.  On April 2, 2009 the agency issued Notice of Violation letters to 14 companies who sponsored links on internet search engines advertising their products; the links gave the name of the drug and, in some cases, its indicated use, without including the required “fair balance,” i.e., safety information such as contraindications and potential side effects.  In reliance on the so-called “one-click rule” — which had never actually been adopted by the FDA — the companies had put the required safety information one click away on a separate page.

In recent months, the FDA has indicated that it is open to providing internet-specific marketing guidance.  Yesterday and today (November 13th) the agency is holding a hearing on “Promotion of FDA–Regulated Medical Products Using the Internet and Social Media Tools.”  Representatives from advertising agencies, consumer groups, health-related websites, pharmaceutical companies, and search engines are scheduled to testify.

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Drug Suspected in Michael Jackson Death Subject of Recall

Ritalin-SR-20mg-1000x1000 Results of Michael Jackson’s toxicology tests have not yet been released, but suspicions have centered on the powerful anesthetic and sedative drug propofol, also known by the brand name Diprivan. It was reportedly found in Jackson’s house, and a nurse who worked with him said he begged for propofol to help him sleep. 

Now, some lots of propofol are being recalled for contamination.

Last night, the Centers for Disease Control and the Food and Drug
Administration advised clinicians immediately to stop using propofol
from two lots found to be tainted with elevated levels of endotoxin, a
toxin made by bacteria. Regulators said Teva Pharmaceuticals, the
manufacturer, had begun a voluntary recall of the lots.

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Daschle out at HHS – Sharfstein in at FDA?

Oie_090203_daschle_634The early stages of the Obama administration are beginning to
resemble the Clinton years, which I 
observed from afar (I was a foreign
correspondent in Tokyo at the time). Take Zoe Baird and substitute Tom
Daschle, who dropped out of the running for Secretary of Health and
Human Services today because of tax and conflict-of-interest problems.
Take gays in the military and substitute putting in charge of the bank
bailout a man (Tim Geithner) who knows all the bankers from his years
at the New York Fed, seems overly solicitous to their needs, and has
his own tax problems.

Once again, a new Democratic president appears to have a semi-automatic weapon semi-permanently aimed at his foot.

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Should the FDA relax in the search for new cures?

Over at DiabetesMine #1 health blogger Amy Tenderich has very important post. She and several fellow travelers are appealing to the FDA to strike a balance between safety and progress in allowing new diabetes treatments.

The FDA of course has been beaten to a pulp these last few years because it’s played footsie with the drug industry and ignored several potentially damning studies, with the result that the number of drugs withdrawn from the market has been much higher than in previous years.(Vioxx, Phen-Fen, Baycol, et al).

I’ve always felt that the FDA’s role should not to be a black/white (dangerous/safe) stamp of approval, but instead it should be the honest broker of getting all the data out there. As Amy and her crew point out, some diabetics may be prepared to take a risk of higher long-term cardiac complications in return for a medium term gain from a new medication. Something similar is certainly true in terms of hormone replacement therapy.

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Weighing in on the New FDA Commissioner

Patient
advocacy groups, most of them drug industry-funded, have asked
President-elect Barack Obama to appoint a Food and Drug Administration
commissioner who won’t cave in to pressure from lawmakers or the news
media, according to the Wall Street Journal.

It is news to me that the news media has much say about decisions at
FDA. There are reporters who highlight problems, especially safety
problems, in the nation’s food and drug supply. And there are reporters
who highlight every study suggesting the next miracle cure is just
around the corner. Large news organizations like the New York Times
have both. For every Gardiner Harris, there is a Gina Kolata. The news
media are megaphones. They are not, to use someone else’s phrase, the
decider.

Vioxx and Avandia didn’t come to light because of the press or angry
legislators on Capitol Hill. What consumers and patients, legislators
and the press learned about the lethal side effects of those drugs was
due to diligent researchers like Steve Nissen and Eric Topol and
courageous whistleblowers inside the FDA like David Graham. Ditto for
most of the other safety scandals that have plagued the agency in this
decade.

That said, patient advocates who are worried that the agency under a
more safety-conscious commissioner will somehow abandon the search for
faster cures should know that their views are well represented inside
the transition team. Josh Sharfstein, the Baltimore health
commissioner, formerly on Rep. Henry Waxman’s staff, who took up cause
of making pediatric cold medicines safer, may be leading the effort.
But his co-conveners include Greg Simon, who heads a group called . . .
da da . . . Faster Cures (not industry-funded, according to Simon). The
other team leader is attorney Alta Charo from the University of
Wisconsin, whose expertise is primarily in bioethics, not drug safety.

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Who should Obama pick for FDA Commissioner?

It seems like everyone in the Pharma Blogosphere and the press is recommending who president-elect Barack Obama should nominate as the new FDA Commissioner to replace Dr. Andrew von Eschenbach.

A few weeks ago, I created the “Who Should Obama Nominate for FDA Commissioner?” online survey to determine who readers of Pharma Marketing News think should be the next FDA Commissioner. I received many interesting comments and decided to open the survey up to as many stakeholders as possible, including consumers, healthcare professionals, former FDA and other government officials, pharmaceutical employees, and others.

I hope readers of The Health Care Blog will also participate (see how below) and I thank Matthew for allowing me to make this post to THCB.

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Americans’ Confidence in the FDA Falls Sharply

File799652Confidence in the FDA has hit bottom.
The latest survey on trust in the FDA comes from Harris Interactive, who regularly surveys the public’s faith in the regulator.

Consumers
see the FDA’s #1 job as "ensuring the safety and efficacy of new
prescription drugs," cited by 61% of the public; however, 58% of people
have a negative view of the FDA’s role in this job, compared to only
35% who think positively about the FDA’s performance in this key role.

This latest drop in confidence in the FDA is driven by the Heparin scare, blogged about here.

Other factors eroding confidence in the FDA include toy safety, food safety,
the recent toothpaste scare, and perceived lags in approving necessary
drugs.

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WSJ Editorial on Liver Transplants Cherry-Picks the Numbers

Dr. Scott Gottlieb, a resident fellow at the conservative American Enterprise Institute, published an op-ed in the Wall Street Journal last week that returned to the much-exploited story of Nataline Sarkisyan, the 17-year-old Californian who died before receiving a liver transplant. Gottlieb used the story to make the argument that “the U.S. has the best health care in the world.”

Gottlieb is squaring off against John Edwards, who has been suggesting that if Nataline had lived in a European country she might have lived.  Edwards blames CIGNA, her for-profit insurer, for refusing to cover the procedure. Dr.  Gottlieb, who is a former FDA official, responds with a double-barreled argument: “Americans are more likely than Europeans to get an organ transplant, and more likely to survive it too.”  He sounds confident, and at first glance, his argument seems persuasive.

But a closer look reveals that Gottlieb makes his case by carefully culling the numbers that fit his argument, while omitting those that don’t. Unfortunately, too many people involved in the healthcare debate play fast and loose with the facts. Everyone interested in reform should be on the look-out for those who don’t cite solid evidence for their assertions. If they don’t give you their source, it may be because they don’t want you to look it up—and because they realize that they are cherry-picking the numbers.

Before engaging Gottlieb’s argument, I should acknowledge that, as I have said in an earlier post, I think Edwards has picked a bad case to make his argument for healthcare reform. I am not at all certain that the transplant would have helped this particular patient.  And while Edwards puts all of the blame on CIGNA, Nataline’s insurer, I am bothered by the fact that the hospital asked for a $75,000 down payment on the surgery and then refused to go forward without it. As one physician/blogger from the very same hospital where Nataline was treated asked: “Why didn’t the hospital simply perform the surgery and defer payment from the family or CIGNA [Nataline’s insurer] until later? If it was such a great idea, why didn’t they exhibit the outrage and strength of conviction to go ahead regardless of CIGNA’s assessment?”Continue reading…

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