Food and Drug Administration (FDA)

Suit challenges biotech firm over last-chance drug

Anne Zieger — Thu, 17 Jul 2008 12:13:46 -0400

In another case challenging the limits of "compassionate use" for drugs not approved by the FDA, the mother of a gravely-ill teenager has filed a lawsuit demanding access to an experimental drug. The mother, Cheri Gunvalson, argues that the company had promised her that her son would get the drug, but the company, PTC Therapeutics, denies that it made such promises and says the drug isn't ready. Gunvalson, whose 16-year-old son has Duchenne muscular dystrophy, had previously worked on behalf of PTC, which makes a drug she believes offers the best hope for treating her son's version of the condition. However, since the teen is no longer walking--he's confined to a wheelchair--the company says he's not eligible for the clinical trial underway of the experimental compound, PTC124. And they won't give the compound to boys not involved in trials. Gunvalson, for her part, says PTC124 is his best chance to slow or even reverse the effects of Duchenne's.

If PTC did reverse its decision, it wouldn't be a unique decision. Of late there's been a movement toward allowing seriously-ill patients to use experimental drugs, under a process known as compassionate use, which enrolls them in single-patient studies or clinical trials. In her suit, Gunvalson asks for just such an exception, arguing that there are no significant risks and that the compound could possibly save his life.

To learn more about this case:
- read this article in The New York Times

PLUS: The controversy over this case hasn't slowed PTC down. In fact, it just finalized a $437 million licensing deal with biotech Genzyme for its lead development program. FierceBiotech

SPOTLIGHT: FDA chief blasts Red Cross

Anne Zieger — Thu, 17 Jul 2008 01:11:24 -0400

FDA Commissioner Andrew von Eschenbach is out of patience with the American Red Cross, which the FDA says isn't doing a good job with screening some of its blood supplies. In fact, according to The New York Times, between December 2006 and April 2008, the agency distributed more than 200 blood products it had already identified has potentially having problems. The agency concedes it has problems, and says it's working to fix them. In the mean time, it's toe to toe with von Eschenbach, who has threatened criminal sanctions over blood screening problems. Blog

FDA says CT scans can make medical devices malfunction

Anne Zieger — Tue, 15 Jul 2008 09:39:22 -0400

The FDA has issued a warning that some critical electronic devices may malfunction when patients get CT scans. In fact, CT scans may actually cause some medical devices to shock patients using them, or send out inaccurate signals, the agency said. This squares with an earlier study, published by Mayo Clinic researchers, which found that CT scans often interfered with electronic heart devices. Devices on the FDA's warning list include pacemakers, defibrillators, insulin pumps, neurostimulators, drug infusion pumps, cochlear implants and retinal implants. To date, the FDA has received six confirmed reports of devices that malfunctioned after CT scans, as well as another nine reports of suspected problems, though no deaths have occurred to date.

To learn more about the alert:
- read this Chicago Tribune article

Related Articles:
Trend: Providers increase use of CT scans
Trend: CT scan usage climbing, raising radiation fears
New CT scanner breeds demand, controversy
MD self-referrals for imaging slipping through

SPOTLIGHT: Revised study still finds that FDA approval rush may cause harm

Anne Zieger — Thu, 03 Jul 2008 01:26:37 -0400

Harvard University professor Daniel Carpenter has come out with a revised version of a study concluding that drugs moving too quickly through the FDA approval process are more likely to be linked to safety problems later. Though admitting to data mistakes in his original study, he stands behind his original conclusion, Carpenter says. According to his new numbers, between 1993 and 2005, 88 drugs approved near agency deadlines had a 15 percent chance of being identified as having severe safety problems, as compared with 5 percent of 226 other drugs. Article

FDA sued over failure to ban painkiller

Anne Zieger — Fri, 20 Jun 2008 13:14:36 -0400

A consumer group has sued the FDA over its failure to remove a prescription painkiller from the market, arguing that it's too dangerous to stay on the market. The group, Public Citizen, had petitioned the FDA two years ago for it to ban the drug, propoxyphene, sold under such names as Darvon and Darvocet as well as many generic formulations. To date, the FDA hasn't responded to the group's request.

Now, Public Citizen has filed suit in U.S. District Court in Washington, arguing that the agency had violated the law by not ruling on its petition within the required six-month period. In its materials, the group argues that the propoxyphene is no more effective than other safer painkillers, noting that since 1981, there had been 2,000 accidental deaths associated with it. It also notes that even when used properly, propoxyphene is addictive and can cause serious cardiac side effects.

If the FDA did ban propoxyphene, it would be following in the steps of British health authorities, who ordered the drug to be withdrawn from use in 2005, citing accidental deaths and suicides. Still, right now it remains one of the most widely prescribed generic drugs in the U.S.

To learn more about the case:
- read this Associated Press article
- read the Public Citizen press release

Related Articles:
Public Citizen joins FDA review
Report faults FDA's post-marketing vigilance
FDA rejects Public Citizen's demand to pull Meridia

FDA to notify doctors of drug, device issues via Internet

Anne Zieger — Wed, 18 Jun 2008 11:21:15 -0400

Hoping to speed up the process by which doctors learn that a drug or device may pose a danger to patients, the Food and Drug Administration has started working with the AMA, physician specialty groups, drug and device manufacturers and liability insurers to promote an Internet-based warning system. Traditionally, doctors have received notifications via standard paper mail when the FDA learns that there's a threat involved with a drug or device. However, professionals hope that the new Health Care Notification Network will speed up the notification process dramatically. More than 100,000 doctors already have signed up for the HCNN, which should launch in July.

The service, which is free to physicians, is being funded by drug and device-makers. Network developer Medem Inc. estimates that using the HCNN, doctors should get notified of drug and device issues within a day or two, rather than the three to four weeks it now takes for drug and device-makers to draft a letter, get FDA approval, print and mail it out. The AMA, which is one of seven medical societies behind Medem, is encouraging its members to enroll.

To learn more about the network:
- read this AMNews article

Did Glaxo conceal Paxil users' risk of suicide?

Fri, 13 Jun 2008 06:59:55 -0400

Did drugmaker GlaxoSmithKline conceal suicide risks for users of its antidepressant Paxil within the mountains of data it submitted to the FDA? That's a question Sen. Chuck Grassley (R-Iowa) would like to see answered, and in some detail. Grassley would like to find out who within Glaxo knew what, and when, about the medicine's possible link to increased suicidal behavior. In his correspondence with the FDA and HHS Secretary Michael Leavitt, Grassley notes that the U.K. recently concluded that the firm withheld safety information when submitting data for approval in Europe. Now, he wants to know whether Glaxo did the same in the U.S. In testimony on the Senate floor, Grassley noted that a report by one Harvard researcher contends that Glaxo probably knew about Paxil safety concerns all the way back in 1989, when it first asked the FDA for approval--and that it probably manipulated studies to diminish the perceived risk.

To learn more about Grassley's concerns:
- read this Wall Street Journal blog entry

Related Articles:
Study highlights link between Paxil and suicide
Glaxo wins Paxil suicide case
FDA says Glaxo didn't report Avandia data

ALSO NOTED: Hospital group says quality reporting too costly; Health IT 'name game' creating headaches; and much more...

Fri, 13 Jun 2008 06:59:50 -0400

> The Premier Healthcare Alliance, which represents 2,000 hospitals across the U.S., is raising a stink over new quality reporting standards it says are far too costly to implement. FierceHealthFinance

> Sometimes, a good idea simply doesn't work out in practice. It's looking like the federal group whose job it is to provide good definitions for key IT terms may be creating more confusion than it solves. FierceHealthIT

> Sen. Arlen Specter (R-PA) is accusing the Bush administration of dragging its feet when it comes to giving the FDA the $275 million more it's requested. Specter wants to see the FDA get it this year, but the administration wants to put the funding off until fiscal 2009. FiercePharma

> It looks like Baxter may be getting closer to offering a commercial version of a bird flu vaccine that fights three lethal strains of the virus. FierceVaccines

And Finally... Just in time for summer, healthy ice cream that might actually be worth eating. Article

ALSO NOTED: Hospitals working to avoid needless ED care; FDA may soon require epilepsy drug labeling; and much more...

Thu, 12 Jun 2008 06:59:50 -0400

> Hoping to avoid further bad debt, hospitals are setting systems in place to avoid providing non-emergency ED care. FierceHealthFinance

> The FDA is close to a deal with drugmakers that would require warnings to be added to the the labeling on epilepsy drugs. FiercePharma

> The federal office of the National Coordinator for Health IT has released its five year plan, focused largely on patient-focused healthcare and population health. FierceHealthIT

> The University of California may end up taking over the vast task of reopening Martin Luther King Jr.-Harbor Hospital, which was shut down after years of problems and the loss of its CMS certification. Article

And Finally... This guy was determined to make it to court--no matter what. Article

FDA may get $275 million more for staff, outsourcing

Wed, 11 Jun 2008 06:59:54 -0400

The Bush administration is asking Congress for an additional $275 million for fiscal 2009 to allow the FDA to add more workers, expand programs and technology, and perhaps most interestingly, outsource some of its regulatory work. Given an earlier FDA request to expand its budget, the total added funds would come to about $404.7 million in fiscal 2009 than fiscal 2008, a 17.8 percent climb in spending. This will allow for 490 new FDA jobs. The funding request also asks Congress to expand FDA authority, notably to outsource some of its regulatory work by accrediting independent, third-party organizations to conduct voluntary inspections. These organizations would have the right to ban imports by a company if it delays, limits or denies access to agency inspectors.

To learn more about the new FDA budget (and outsourcing plans):
- read this Modern Healthcare article (reg. req.)

Related Articles:
FDA says it needs bigger budget
FDA moves to allay drug-import fears
FDA can't guarantee drug safety