FDA news

Did FDA counsel save Procrit ads?

Tue, 13 May 2008 06:59:56 -0400

Remember that DTC hearing in Congress last week, when Rep. Bart Stupak alleged that Johnson & Johnson kept pushing its anemia drug Procrit as a fatigue-buster, despite the FDA's admonitions? Testimony on the subject came with a bunch of documents, which The Cancer Letter dug through--to find that the FDA's chief counsel may have intervened on J&J's behalf to keep the ads on the air.

The agency had questioned J&J's advertising, saying its implication that Procrit improved strength and perhaps survival was misleading. Somewhere along the line, the Office of Chief Counsel became involved; notes from a 2002 teleconference show that the OCC asked the staff to "try to find middle ground" and to avoid "yanking" the ad campaign. (The chief counsel at the time of the teleconference is now in private practice.) The ads continued to run through 2005. Experts told The Cancer Letter that they think the episode should be reviewed by agency ethics officials.

Meanwhile, a Government Accountability Office report shows that the FDA drags its heels on issuing warning and untitled letters about DTC ads: Six months on average, and in one case, more than three years. Before 2002, when the FDA decided to submit all draft letters for legal review--by the Office of Chief Counsel--they went out in less than a month.

- find the GAO report here
- see the brief in The Cancer Letter
- get more from Pharmalot
- check out the article at FDA News

How the FDA will spend your fees

Thu, 08 May 2008 06:59:55 -0400

Curious how the FDA might spend its PDUFA fees? A new five-year plan shows that FDA will plow the money into post-marketing safety to meet its commitments under the new law passed last fall. The agency would spend the to boost the number of employees looking at new scientific approaches to drug safety, improving adverse event detection and prevention programs, and cutting back on medication errors. Plus, it would invest millions in epidemiology "best practices" and data acquisition. Want more detail? Check out the plan itself on the FDA website.

- see the plan
- check out the story at FDA News

A closer look at industry issues

Tue, 22 Apr 2008 06:59:59 -0400

As we announced several weeks ago, FiercePharma will be featuring a new special section called Industry Voices. A variety of columnists will discuss issues affecting the pharmaceutical industry and examine the trends that are changing the way drug makers do business. We hope this feature will give you deeper insight into larger issues that don't always make the daily news cycle.

Our first columnist is Mark Senak, an industry expert with over twenty years of experience in law, communications, public health and public relations. He is also the author of Eye on FDA, a popular blog covering the ins and outs of FDA news and policy. Scroll down to check out his article on the recent upheaval at the FDA, or click here to read it online. - Maureen

FDA's China office opens next month

Tue, 15 Apr 2008 06:59:56 -0400

FDA watchdogs will move into China next month, HHS Secretary Mike Leavitt said. The agency's Chinese office signals a new approach toward food and drug safety, he said; it's too tough to try to catch unsafe products at the U.S. border. "[W]e're changing our strategy... to building safety into the products," he said.

Heading up the China office will be Christopher Hickey, currently director of HHS' Asia and Pacific office. Though FDA staff will start working there next month, the office won't officially be open till October. According to previous reports, the agency plans to establish eight FDA positions at U.S. diplomatic posts in China and to hire five Chinese employees in key cities.

The new office, of course, is a response to a string of contaminated products coming out of China. Most recently, tainted heparin whose active ingredient was made in China forced a massive recall; the drug has been linked to 62 deaths and hundreds of allergic reactions. The new office also affirms the current realities of the drug industry: About 40 percent of drugs and 80 percent of their ingredients are imported, a growing number from countries such as China and India, where drug-safety controls are new. Leavitt said the U.S. plans to build a presence in other countries besides China, such as India and Central America.

- read the Associated Press story
- see the article in the Wall Street Journal

Related Articles:
FDA moves to allay drug-import fears. FDA report
Americans distrust drugs from China, India. Drug report
FDA wants satellite offices overseas. FDA report
Overseas drugmaking goes unsupervised. FDA report

FiercePharma passes 20K subscribers

Tue, 08 Apr 2008 06:59:59 -0400

Publisher's Note

Last week the FiercePharma newsletter passed the 20,000 subscriber mark. Thousands of more people are reading via the website and RSS feeds, and I want to thank everyone who has made FiercePharma part of their daily schedule over the last 6+ months.

While we are pleased to pass this milestone, we continue to look to build on our efforts. Today I'm excited announce two items that we have on the upcoming schedule.

A line-up of new industry contributors--We've arranged for a number of industry experts to provide in-depth guest commentary on topics such as reimbursement, DTC issues, FDA news, sales and marketing, generics, and manufacturing. Guest columnists will include Mark Senak from Eye on FDA, Robert Goldberg from the Center for Medicine in the Public Interest, and Rhonda Greenapple from Reimbursement Intelligence. We are always open for more contributors. Drop me a line if you have something to say that can add to the publication.
Fierce networking parties during DIA and BIO--We've often fielded requests to host an event that will allow members of the Fierce community to get together. This year we're hosting an open cocktail reception during the DIA and BIO tradeshows, so look for registration information in the coming weeks. If your company is interested in participating in either party as a sponsor, send an email to Arsalan Arif.

As always, I'm interested in hearing from you. How are we doing? What can we do to make FiercePharma even more valuable to you? Feel free to send me your suggestions, praise, or criticisms.

Best,

Sean Griffey

P.S. If you enjoy FiercePharma, please tell your colleagues and friends. They can subscribe for free here!

Planning for the FDA's overhaul

Tue, 08 Apr 2008 06:59:58 -0400

Just about everybody agrees that the FDA needs a safety overhaul--including Commissioner Andrew von Eschenbach, who recently admitted the agency is in crisis. The agency itself drafted a five-year plan that would channel user fees into more safety evaluators, epidemiologists, regulatory project managers, and risk experts, all to beef up post-marketing drug-safety oversight. In addition to new staff, the plan calls for technology and communications systems, plus two or three years of intense staff training.

Meanwhile, Rep. John Dingell has been working on a plan of his own. According to Congressional Quarterly, Dingell would expand the FDA's regulatory authority by funding a team of full-time overseas inspectors. He'd require drugs, devices, and food products to be labeled according to country of origin. He'd levy new user fees to pay for spot checks at overseas plants and U.S. ports. Sweeping change is absolutely necessary, Dingell tells CQ, saying that the agency doesn't have "the vaguest idea who's producing these things, whether they're safe or not, whether they're using good manufacturing practices or not...or anything else that might relate to seeing to it that the safety of the American people is attended to." Ouch.

- read the Dingell item at Pharmalot
- see a summary of the FDA plan at FDANews
- check out the FDA's plan draft (.pdf)

ALSO: The San Jose Mercury News' editorial board says the FDA should be embarrassed by its lack of attention to the ingredients in prescription drugs--and that its laissez-faire foreign inspections make its refusal to import cheaper prescription meds (for "safety reasons") into "hypocrisy." Report

Related Articles:
FDA chief admits need for funding, reform. Report
FDA can't guarantee drug safety. Report
FDA wants satellite offices overseas. Report
FDA badly needs more money, staff. Report

Should FDA's info be in all DTC ads?

Thu, 03 Apr 2008 07:59:56 -0400

First consumers, now Congress. Two lawmakers asked the FDA yesterday to mandate that all TV ads for prescription drugs include contact info for patients to report serious side effects to the agency. The impetus? A Consumer Reports poll that showed 16 respondents had a side effect serious enough to send them to the doctor or hospital--but 35 percent of respondents didn't know they could report side effects to the FDA.

FDA tracks side effects from prescription and OTC meds, but officials estimate they learn about fewer than 10 percent of drug reactions. Consumers Union, which publishes Consumer Reports, sent the agency a petition with 55,000 signatures, requesting that a toll-free number and web address be included in TV drug ads. An agency spokeswoman said it's reviewing the petition.

Already, Congress passed legislation requiring contact info to be placed in all DTC print ads and calling for an FDA study of doing the same in TV commercials. That study is still ongoing, the spokeswoman said.

- check out the Consumers Union survey
- read the Los Angeles Times story
- see the item in the WSJ Health Blog

ALSO: The FDA appears to be close to unveiling its plans for a national surveillance network to keep tabs on drug safety. The "Sentinel" project has to address a number of key questions first, though. Such as, how will prescription info be kept private and secure? And how will the system be insulated from political and industry influence? Report

Related Articles:
FDA to study TV drug ad imagery. Report
Survey: No doubt DTC ads work. Report
Watchdogs circling DTC drug commercials. Report
Study: DTC ad spending on the rise. Report
Does the FDA do enough to regulate drug ads? Report

FDA pleas for funding gaining traction?

Fri, 29 Feb 2008 06:59:57 -0500

If there's a silver lining in the heparin cloud, it could be this: Suddenly, the FDA asking for more money to fund overseas inspections isn't just a theoretical or precautionary measure. When Center for Drug Evaluation and Research honcho Janet Woodcock told Congress Wednesday that the FDA needed to beef up foreign oversight, reps quickly connected that call to the agency's failures vis-à-vis heparin.

They also appeared eager to give Woodcock what she wanted--at least while speaking publicly. (It didn't hurt that this gave the opportunity for Democrats to bash the Bush administration for cutting foreign-inspection funding since taking over.) They pressed her to say how many more inspectors would be needed. She couldn't specify, but did say that not only staffers but better computer tracking systems were needed.

Meanwhile, the House Committee on Energy and Commerce released ambitious funding numbers for the agency, generated by members and advisors to the FDA's Science Board. Criticizing the Bush budget, Reps. John Dingell and Bart Stupak said the agency needs an funding increase nine times the figure the president has proposed. Whether any of this posturing actually translates into real dollars remains to be seen.

- see the Associated Press article
- read the press release from Energy and Commerce

Related Articles:
FDA chief admits need for funding, reform. Report
The FDA: Caught between a rock and a hard place. Report
Agreed in committee: FDA needs money. Report
FDA badly needs more money, staff. Report
FDA can't guarantee drug safety. Report

Agreed in committee: FDA needs money

Wed, 30 Jan 2008 06:59:58 -0500

As expected, FDA was taken to the woodshed yesterday, as experts told a Congressional committee that the agency was underfunded, understaffed, overburdened, and seriously behind the times. And Commissioner Andrew von Eschenbach, contrary to usual committee practice, was forced to listen to hours of testimony before he was given his chance to speak.

Also as expected, the experts pleaded for more FDA funding. One said the agency needed double its $2 billion annual budget and a 50 percent increase in staffing, because more than 100 statutes have increased the FDA's duties since 1988, without additional money to handle them. Several congressional reps agreed that FDA needs more money. But the Government Accountability Office report that was one of the hearing's subjects pointed out that the FDA also "has opportunities to better leverage its resources." The GAO suggests that, to persuade Congress to give it more funding, the FDA should detail exactly how it would use the additional money.

Meanwhile, as part of their probe of Sanofi-Aventis' antibiotic Ketek, the same Congressional committee was preparing subpoenas for FDA officials. At the top of its list: Health and Human Services honcho Michael Leavitt, who oversees the agency. Others include two FDA investigators and one former investigator. The investigation is focused on whether Sanofi knew about "substantial data integrity problems" with a study when it was submitted to the FDA. The company has said that it acted in good faith in conducting that study; it's cooperating with the investigations.

- read the report from the Philadelphia Inquirer
- check out MarketWatch's coverage
- see this article from WTHR-TV
- here's the Wall Street Journal Health Blog's item on Ketek

Related Articles:
GAO assails FDA's foreign inspections. Report
FDA wants satellite offices overseas. Report
FDA badly needs more money, staff. Report
FDA can't guarantee drug safety. Report
Overseas drugmaking goes unsupervised. Report

Panel: Give FDA power to recall

Tue, 06 Nov 2007 06:59:58 -0500

More power to the FDA. A presidential panel is set to recommend giving the agency the authority to recall products all by its lonesome. It would be a sea change; now, the FDA can only pressure companies to voluntarily withdraw their wares. The advisory committee--convened in response to the spate of toy, pet food, and toothpaste recalls--would also give the FDA power to cut off imports from companies that won't pony up all of their production info.

The recommendations are just that unless and until Congress takes action. And some say they don't go far enough; for instance, they don't call for "trace back," or a system to follow the production chain to find where contaminations occurred. Others said they'd be worthless unless adequately funded, and as we know from recent reports of overseas inspections, there's not much precedent for backing up power with pennies.

- read the report from CNN
- check out the article from the Wall Street Journal

Related Articles:
FDA can't guarantee drug safety. Report
Overseas drugmaking goes unsupervised. Report
Final FDA bill lacks new DTC oversight. Report
House overhauls, passes PDUFA. Report
FDA offers safety reforms to skeptical lawmakers. Report

Read more on: FDA news

FDA can't guarantee drug safety

Fri, 02 Nov 2007 07:59:57 -0400

The government's own auditor says FDA is failing. Testifying before a Congressional subcommittee yesterday, the director of healthcare for the Government Accountability Office said the agency can't guarantee the safety of the U.S. drug supply because its oversight of foreign drug manufacturers is horribly lax. The agency's record-keeping is so poor, it doesn't even know which facilities haven't been inspected, the GAO rep said.

And at the current rate of inspection, it would take the agency 13 years to examine each facility once--and those are just the factories it knows about. Volunteers often conduct inspections. And the facilities are given advance warning that inspectors are coming. Luckily, U.S. drug makers don't rely on the FDA to ensure its foreign suppliers are delivering quality goods. The companies conduct their own inspections, and they test some shipments to make sure they're OK.

- read the report from the New York Times

Related Articles:
Overseas drugmaking goes unsupervised. Report
Poll finds problems at the FDA. Report
FDA offers safety reforms to skeptical lawmakers. Report
IOM slams FDA, calls for major reforms. Report

Overseas drugmaking goes unsupervised

Wed, 31 Oct 2007 07:59:56 -0400

Look no further for a couple of gaping holes in our drug-safety fabric. Chinese regulators may be cracking down on some drug-safety violations, but plenty of chemicals companies aren't even being watched. Stateside, the FDA is struggling to track foreign drug makers--and that not very successfully.

First, the Chinese chemicals firms. According to a New York Times investigation,they're making pharmaceuticals ingredients, but many aren't certified or inspected by the government. They aren't required to meet any drug-manufacturing standards. Some even make finished drugs without any supervision whatsoever. And dozens of them--including known counterfeiters and poison-passers--came to a pharma trade show to sell drug makers on their products.

Next, the poor, underfunded FDA. According to a Congressional memo obtained by the Wall Street Journal, the agency can't even keep track of how many foreign drug makers it should oversee. And those it does know about are inspected only once every 8 to twelve years. Problems with foreign oversight were identified a decade ago--but they're still uncorrected. This at a time when drug and ingredient imports are skyrocketing. Agency officials say they do know who's importing drugs to the U.S. and that they focus inspections on products that pose the greatest risk. But they admit funding is down, and so is staffing.

- check out the NYT article on unregulated Chinese manufacturers
- read the WSJ report about FDA's lack of foreign oversight

FDA mulls behind-the-counter drug sales

Thu, 04 Oct 2007 06:59:57 -0400

Once, the gap between prescription drugs and over-the-counter sales was a wide No Man's Land where few products roamed. Now, the FDA may settle more medications in this country, known as behind-the-counter (BTC) sales, in part to improve access for the uninsured.

The agency is seeking public comment on the potential move, which would allow patients to buy certain remedies after consultation with a pharmacist. Though the FDA won't cite specific meds that might be included, experts cite birth control pills and cholesterol-lowering remedies as possibilities.

- see the AP article

Related Articles:
House overhauls, passes PDUFA. Report
FDA clears Plan B, ending FDA confirmation fight. Report

Pharma, FDA to study adverse events

Thu, 27 Sep 2007 06:59:58 -0400

When it comes to predicting who'll suffer severe drug side effects, seven heads are better than one. Such is the hope of a Big Pharma consortium formed to track down genetic risk factors for serious adverse events.

The group--which comprises Pfizer, Abbott Laboratories, GlaxoSmithKline, Johnson & Johnson, Roche, Sanofi-Aventis and Wyeth--will pool their data on Stevens-Johnson syndrome, a rare but potentially fatal drug reaction, and liver toxicity. Both side effects occur infrequently, but can be caused by multiple drugs.

Theoretically, it's more evidence of the Brave New World of personalized pharma. But would every patient prescribed a potentially risky drug get the right genetic test? Or would sifting out the vulnerable patients have to wait until we're all carrying ID cards embedded with our personal DNA?

- check out this release for details on the program
- read the New York Times article

Related Articles:
House overhauls, passes PDUFA. Report
Bickering may stall trial database. Report
PDUFA debate highlights drug safety issues. Report
Senate toughens drug safety supervision in PDUFA bill. Report

FDA taps new-yet-old drug chief

Mon, 24 Sep 2007 06:59:57 -0400

As the ink was still drying on the new drug-safety bill, FDA shuffled its management, bringing back Janet Woodcock as director of the Center for Drug Evaluation and Research. The previous director, Steven Glason, will take over as acting Surgeon General October 1.

Woodcock held the reins at CDER for more than 10 years before becoming deputy commissioner. She'll need that experience to take on the safety overhaul ordered by Congress--which involves a bigger budget, more power, and lots more responsibility to seek out unsafe drugs before a Vioxx-like disaster strikes.

- see the FDA commissioner's statement
- read this piece from The Wall Street Journal (sub. req.)

Related Articles:
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Drug safety system 'broken'. Report
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Final FDA bill lacks new DTC oversight

Fri, 21 Sep 2007 06:59:55 -0400

The Senate overwhelmingly passed the drug-safety and FDA funding bill yesterday and sent it along to President Bush for his signature. Experts are calling it a sea change in the FDA's operations. Instead of waiting for reports of adverse events to roll in, the agency will be on the prowl for evidence--digitally, through its new surveillance system and clinical trials database, and non-digitally, by ordering post-approval trials. Questions: Will the agency figure out how to separate false alarms from real read flags? Can it target its post-approval trials appropriately? There's nothing to do but watch and wait.

Interestingly, the final version of the bill is a bit toothless when it comes to regulating drug ads. Apparently, the media industry helped pharma fight provisions that would have allowed the FDA to force changes in direct-to-consumer advertising. Now, the agency will only be able to recommend them.

- read the analysis in the Los Angeles Times
- read this Wall Street Journal article on the media's pro-DTC lobbying

Related Articles:
House overhauls, passes PDUFA. Report
FDA: 2,000 layoffs if PDUFA not passed. Report
Bickering may stall trial database. Report
10 reforms for drug advertising. Report
Does the FDA do enough to regulate drug ads? Report

House overhauls, passes PDUFA

Thu, 20 Sep 2007 06:59:58 -0400

Congress kicked their work on an FDA funding bill into gear--after the FDA commissioner gave them a kick in their collective pants. The commissioner threatened to lay off workers if the agency didn't get its funding by tomorrow's deadline, so the House scrambled to approve a measure that would boost FDA funding and revamp its drug-safety system. The bipartisan compromise bill still awaits approval by the Senate.

The renewed PDUFA would increase the fees paid by drug and device makers when they submit products for approval. And it would boost the FDA's power to monitor drugs after they're put on the market. The agency could order companies to perform clinical trials, for instance, and could issue warnings earlier than it could before.

The bill also sets up a high-tech surveillance system to try to spot safety problems earlier, and, as expected, calls for a public-access database of all clinical trials. So hold on to your pink slips, Mr. Commissioner. It looks as if you'll get your money.

- see this statement from the bill's lead author, Rep. Frank Pallone (D-NJ)
- read the story from the Los Angeles Times

Related Articles:
FDA: 2,000 layoffs if PDUFA not passed. Report
Bickering may stall trial database. Report
Congress juggles two crucial drug bills. Report
PDUFA debate highlights drug safety issues. Report

FDA to study TV drug ad imagery

Wed, 22 Aug 2007 06:59:57 -0400

Picture this: An FDA type is reclining in his Barcalounger, watching a few direct-to-consumer ads. Homework. Between bites of popcorn, the FDAer notices something strange. The rolling video in these ads shows healthy, smiling, carefree people--you can almost hear Snow White singing in the background. Almost. Because what you hear instead is a monotone voice reciting a litany of terrible side effects. Anxiety and sleeplessness, weight gain, blood clots that can be fatal, and so on.

What's a diligent agency to do, then? Mount a study. The FDA intends to show a selection of drug ads to 1,000 people over the age of 40, and then ask questions about the subjects' impression of the drug. Are any verbal warnings penetrating the fairy-tale fog induced by those happy-go-lucky images? We'll see.

- read the Wall Street Journal's take on this (sub. req.)

Related Articles:
Study: DTC ad spending on the rise. Report
Does the FDA do enough to regulate drug ads? Report
GAO: Improvements Needed in FDA's oversight of DTC ads. Report

FDA quick to reject drugs as it gets more cautious

Mon, 20 Aug 2007 06:59:58 -0400

Is the FDA getting gun-shy? The agency has rejected so many drugs this year--and slapped warnings on so many others--that industry observers suspect the agency of a self-preserving caution. It's approved only 61 percent of drug applications so far this year, compared with 73 percent during the same period of 2006, according to BioMed Tracker. New molecular entities--drugs based on totally new chemical compounds--have perhaps fared worst. Only seven have been given the FDA go-ahead this year, compared with an average of 12 during the same seven months of every year since 1998.

None of this is news to battle-scarred drug companies, from Big Pharma on down. But the FDA says it hasn't made any systematic changes in its drug review process. Some experts say the jury's still out. Besides, with so many drugs getting pulled offstage after the show's already started, pre-opening night jitters might not be an excess of caution, but an increase in common sense.

- read the article from The Baltimore Sun

Related Articles:
Industry exec says FDA approval process too strict. Report
Poll finds problems at the FDA. Report
FDA offers safety reforms to skeptical lawmakers. Report
IOM slams FDA, calls for major reforms. Report

Novartis' Reclast gets FDA blessing

Mon, 20 Aug 2007 06:59:57 -0400

Score one for Novartis. Its once-yearly treatment for post-menopausal osteoporosis, Reclast, now has the FDA's blessing. Already approved in the U.S. and E.U. for treatment of Paget's bone disease, the drug is expected to win approval in Europe within three months.

It's a big deal for the drug maker: Analysts expect sales of Reclast to reach $1 billion in sales. As a once-yearly treatment, it doesn't have to be taken every day as other osteoporosis remedies do, and a three-year trial showed a 70 percent decrease in certain types of fractures due to the disease. With the Baby Boom in menopausal territory, the drug has a huge potential market.

- see this press release
- read the AFX report for more

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