Tag: FDA

Independent Advisors Prove Independent

Sep 3, 2010• 10

By MERRILL GOOZNER
Journalist-turned-stock-analyst Ramsey Baghdadi of Concept Capital, who formerly wrote for the RPM Report, tells TheStreet.com that Food and Drug Administration Advisory Committee recommendations are down to 52 percent “yes” votes this year, “the worst year since 2007.” He compares that unfavorably to 2009 and 2008 when the advisors gave positive nods 75 and 80 percent of the time.

Reasons for the tougher regulatory environment, according to Baghdadi? “First, the FDA is bringing more drugs in front of advisory panels due to changes in FDA law that require most new drugs to be reviewed by outside experts,” the article notes. “Second, stricter conflict of interest rules implemented by FDA (in the wake of the 2007 reform law) have made it more difficult for the agency to recruit experienced panel members.”

If inexperienced members without conflicts of interest are more prone to voting no, how does that explain 2007, when the current rules weren’t in place and there were still 50 percent “no” votes?Continue reading…

“FDA More Pro Industry Than Any Time in 35 Years”

Jan 16, 2010• 7

By MERRILL GOOZNER

Merrill

So says Jim Dickinson, editor of FDAWebview, an industry newsletter that closely follows enforcement issues at the agency. After reviewing the deregulatory shifts at the Food and Drug Administration since the Carter administration, he writes:

It has taken almost a generation, but by now, the pro-industry infiltration of FDA’s culture is firmly entrenched. Not only is collaboration in product reviews officially encouraged, but good relationships across the regulatory fence hold the prospect of a possible future career in a well-paid industry job – a connection that is less likely to be publicly noticed in news media that now have to line up for information that has been filtered through agency press offices. The arm’s-length relationship that formerly ruled every contact between agency and industry has become a fading memory.

He says the shift in culture accelerated after the 1992 passage of the Prescription Drug User Fee Act, which made the agency dependent on industry funding. He concludes there’s nothing that Margaret Hamburg, the new commissioner, and Joshua Sharfstein, her deputy, can do about it. Quoting a former chief of enforcement, he writes:

User fees at FDA are the primary villain, because they “allowed the industry to dictate the changes at the FDA in programs, procedures and practices. It will be impossible for the Obama administration to reverse the trend because as long as the user fees are in place the industry has the upper hand.”

Radical stuff from an unexpected source.

Health Journos Protest FDA Interview Rules

Dec 4, 2009• 4

By MERRILL GOOZNER

The Association of Health Care Journalists, the Society of Professional Journalists and 9 other scribbler groups have asked the Food and Drug Administration to lift its requirement that agency officials first get permission from the public relations office before speaking with reporters. The demand came in a letter sent to Principal Deputy Commissioner Joshua Sharfstein, who is running the FDA's Transparency Task Force.

Good idea. In fact, it should be extended to every government agency.

Drug Suspected in Michael Jackson Death Subject of Recall

Jul 3, 2009• 5

By SHERI FINK

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.

Daschle out at HHS – Sharfstein in at FDA?

Feb 6, 2009• 21

By MERRILL GOOZNER

The 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.

Should the FDA relax in the search for new cures?

Jan 9, 2009• 1

By Matthew Holt

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.

Weighing in on the New FDA Commissioner

Dec 21, 2008• 1

By MERRILL GOOZNER

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.

Who should Obama pick for FDA Commissioner?

Dec 10, 2008• 8

By John Mack

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.

Americans’ Confidence in the FDA Falls Sharply

Apr 23, 2008• 7

By Jane Sarasohn-Kahn

Confidence 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.