Tag: FDA

Is FDA Getting Ready to Stifle Innovation in Diagnostic Software?

Jul 27, 2011

By DAVID E. WILLIAMS

FDA is proposing regulation for mobile medical applications. Not a bad idea. But I have some concerns about what it will mean for clinical diagnostics software. Here’s the definitional passage:

Mobile apps that allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.

Apps that provide differential diagnosis tools for a clinician to systematically compare and contrast clinical findings (symptoms/ results, etc.) to arrive at possible diagnosis for a patient.

Do EHRs Kill People?

Dec 4, 2010• 56

By MARGALIT GUR-ARIE

Back in the times when EHRs were just EMRs, they had a very simple and humble mission. The software was supposed to help providers of health care services better manage their business. EMRs were supposed to help physicians adhere to CMS documentation rules, automate patient flow management and get rid of all the mountains of paper floating around a typical medical office or hospital. It was assumed that EMR software will increase reimbursement rates, streamline workflow and even make the doctor more efficient. After all, every other industry that switched to computerized business management realized bottom line improvements.

Along the way, bolder statements started appearing, mainly from EMR vendors trying to sell their wares. EMRs could also reduce medical errors. The most common argument was for the benefits of replacing the notoriously illegible physician hand writing. Prescription errors would be reduced if only pharmacists and nurses could get a nice legible script. Then came the frequently misplaced paper charts. If the chart resides in the computer, it cannot be misplaced, it is always available to all and it is complete. All the information you need right at your fingertips, regardless of your physical location. It could save lives or at the very least, it could save time. The EMR was nothing more than an electronic chart. One vendor went so far as to create a computerized image of a yellow manila folder with tabbed pockets for various items in the electronic chart.Continue reading…

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.