Andrew von Eschenbach

Big bonuses for FDA brass rile critics

Tracy Staton — Fri, 11 Jul 2008 08:34:55 -0400

Some time back we heard about the FDA handing out $35 million in bonuses under a new incentive-pay plan. Well, today CBS News has some details. First off, $1 million of that went to 28 top executives. One associate commissioner whose plan to overhaul field labs was rejected as "poorly thought out": $48,000. The director of the office of criminal investigations: $41,000, bringing his total income to $208,000, more than the director of the FBI. The person who reformed the bonus system got the biggest bonus: $58,000. That may not be a lot for, say, a Wall Street banker, but in civil service it definitely is.

FDA Commissioner Andy von Eschenbach explained the bonuses--which averaged $37,000--as necessary to attract and retain "highly experienced, highly capable technical experts." But FDA critics say one quarter of the bonuses went not to technical folk but to bureaucrats, and the same bureaucrats are getting "retention bonuses" year after year. (Maybe a label change is in order?) Also, Congressional investigators say FDA is more lavish with its bonuses than other government agencies are.

What riles Sen. Bart Stupak, a frequent FDA critic, is that the agency hasn't exactly been winning lots of kudos lately. Remember, the FDA's own science board said it's a broken agency, lagging far behind in the science and so woefully under-funded and understaffed that it can't guarantee the public's safety. "They've done such a miserable job these last two years, I think they should leave!" Stupak told CBS. "Not get bonuses of $40,000 to $50,000! Good grief."

- read the CBS article

Frank Torti, future FDA chief?

Tracy Staton — Fri, 13 Jun 2008 11:08:33 -0400

From scientist-in-chief to top chief? Frank Torti, a cancer researcher who joined FDA two months ago, may be in line for the commissioner's job. Beltway wags say the current leader, Andrew von Eschenbach, is likely on his way out after the presidential election in November--no matter who wins. Torti could have the inside track: As scientist in chief, he'd be a logical choice for interim commissioner. And that's how von Eschenbach ended up in the job. Torti's only comment was noncommittal. “I’m not in the habit of taking a job no one’s told me about yet," he told the Pink Sheet. For a peek at his current policy plans, see the RPM Report's link.

- read the RPM Report story
- see the WSJ Health Blog item

Grassley probes dog-drug relaunch

Tracy Staton — Thu, 05 Jun 2008 20:42:35 -0400

It's not just human drug safety that gets Sen. Chuck Grassley into letter-writing mode. When the FDA decided to let a reformulated version of a Wyeth heartworm drug for dogs back onto the market, Grassley fired off a missive to Commissioner Andrew von Eschenbach. What he's worried about is: a. whether the new formula was actually tested on dogs (he alleges the tests were only done on guinea pigs), and b. whether any of the agency meetings about putting the drug, ProHeart, back up for sale involved FDA safety officials. Considering the way people reacted to the big pet food recall last spring, Grassley's vigilance on behalf of U.S. canines could win him some friends in the dog-owner set.

The pharma set? Not so much. Grassley's letter put a safety spin on what Wyeth probably hoped would be an uneventful, but successful reintroduction of ProHeart. The company pulled the previous version of the med in 2004 after reports that 500 dogs died after taking it. Then, Congress held hearings into the FDA's handling of the drug when a staffer said she'd raised questions about its safety--but her superiors shot her down. The new formula, in fact, is coming out under a restricted-distribution program, and its label includes warnings to refrain from administering it within a month of a vaccine.

- read the CNN Money story

FDA, Medicare team up on drug safety

Tracy Staton — Fri, 23 May 2008 09:40:39 -0400

Last fall, the FDA got more power and funding to monitor drugs once they're on the market. Last month, Commissioner Andrew von Eschenbach promised Congress big news on that monitoring, a project that since has been dubbed "Sentinel Initiative." Yesterday, the agency delivered: FDA is teaming up with the Center for Medicare and Medicaid Services on data-mining. FDA will be able to probe CMS's patient databases, actively looking for potential safety problems. Next, the data-mining will move into the private arena via deals with insurance companies; already, the FDA announced a similar partnership with WellPoint.

As you know, the FDA's current after-marketing surveillance is haphazard at best. The agency relies on doctors, drugmakers, and patients to report suspected side effects, but often, doctors and patients don't recognize a problem as a drug side effect or simply don't report their suspicions. Since 2005, there's been talk of some sort of data-mining operation, but it's only now coming to fruition.

Not that scrutinizing databases will make for a perfect system. Medicare claims data can be misleading, and Medicare patients use lots of meds--an average of 28 per year--so teasing out which drug might be to blame for a problem can be, well, a problem. Realizing this, FDA is initially going to use the system to get better data on side effects that already are well known.

Another potential problem, for drugmakers at least: The system will most likely boost the number of drug-safety warnings, at least at first. Some of those warnings could be false alarms. CDER chief Janet Woodcock promises to work to minimize that possibility; we'll see how it plays out.

- find the release from FDA
- see the New York Times story
- check out the Wall Street Journal Health Blog item
- read the Los Angeles Times article

Stupak: FDA needs subpoena power

Tracy Staton — Tue, 20 May 2008 10:05:12 -0400

Rep. Bart Stupak (photo) might be a severe FDA critic, but he's also shaping up to be the agency's dearest friend. Chief of the House Energy and Commerce committee's oversight-and-investigations group, Stupak helped push FDA commissioner Andrew von Eschenbach to ask for millions more in FDA funding--and now he's suggesting that the FDA needs subpoena power. That's no small thing; it would allow the FDA to demand documents from drugmakers rather than simply ask nicely and say please.

Apparently, Democrats on the committee have been rankled by the FDA's lack of power in that department because they think it has limited the agency's pharma investigations. During a recent hearing, Stupak asked CDER honcho Janet Woodcock and her deputy whether they'd like subpoena power; they agreed it would be "very useful." Now, Stupak has written to von Eschenbach asking his opinion on the potential change. He'd like to add it to a drug importation bill now pending in the House. No word on what the commish plans to say in response.

- read the WSJ Health Blog item

The FDA's surprising plea for cash

Wed, 14 May 2008 06:59:55 -0400

Finally, FDA chief Andrew von Eschenbach is crying uncle. After weeks of pressure from Congress to request more money for the agency--and weeks of refusals to specify a figure for beefing up FDA's safety operations--von Eschenbach has asked lawmakers for $275 million, posthaste.

The FDA chief made his plea in a letter to Sen. Arlen Specter that included a detailed plan for spending the money. Among the new expenses: opening new foreign offices, increasing inspections, and building new databases. No big surprises there. But the fact that von Eschenbach made the request--in writing, no less--surprised observers, because presidential appointees tend to toe the administration's budgetary line. Indeed, von Eschenbach himself seemed to be following that tradition, despite the best efforts of Congress to elicit a request for cash.

Not so anymore. "I never saw anything like this happen before," a former FDA commissioner told The New York Times.

- read the Times article

FDA aims to hire 1,300 by October

Thu, 01 May 2008 06:59:57 -0400

In answer to its critics, FDA is mounting a major hiring push to expand its drug safety operations. By October, it hopes to add 1,300 to its payroll--600 new positions and 700 vacancies that have lain unfilled. According to the agency, that's almost three times the number hired during the past three fiscal years.

Who should apply? Potential medical officers, chemists, biologists, microbiologists, epidemiologists, pharmacologists, nurse consultants, general health scientists, and more. The agency will be holding job fairs across the country to troll for job candidates. Plus, FDA got special hiring authority so it can make quick decisions; new hires could be on the job within three weeks.

You'll recall that the FDA's Science Board--and Congressional investigators and other watchdogs--consider the agency seriously understaffed. But hiring these specialized types is no easy task; Commissioner Andrew von Eschenbach said at a recent Senate hearing that it couldn't absorb a recommended $375 million in extra funding in one year because it's so time-consuming to recruit and train new employees.

- see the FDA's release
- check out USA Today's story
- read the article in the Wall Street Journal

ALSO: FDA is working with computer services firm Epocrates to step up doctors' reporting of adverse events, errors, and product quality problems. Release

FDA: Drugmakers responsible for safety

Mon, 28 Apr 2008 06:59:58 -0400

Congress may be all fired up about funding more foreign inspections by the FDA, but the agency itself? Not so much. In multiple appearances before congressional committees, Commissioner Andy von Eschenbach pointedly declined to seek more money for foreign inspections. CDER chief Janet Woodcock went so far as to tell a Senate panel last week that drugmakers need to take responsibility for the quality of their own products.

Increased funding for inspections is all well and good, Woodcock said, but the agency needs better IT systems to track manufacturers and imports, too. And no matter what, the huge volume of pharma ingredients and products made overseas makes it close to impossible to ensure the safety of all drugs sold in the U.S. The FDA can never be "the quality-control unit for the world," she said.

Sounds a lot like the push-back from China early in the heparin scandal, when regulators there said importers needed to bear the responsibility for drug safety. But while China seemed to be simply shoving aside blame, Woodcock is saying that enforcement can't do everything. If drugmakers aren't serious about the quality of their own products from the beginning of their supply chains to the pharmacy shelves, then problem products will get to patients. "We're holding them accountable for their quality system, not being their quality system," she told reporters after her testimony. Maybe what FDA needs as much as new funding is some real power to punish errant manufacturers. Otherwise, this "holding accountable" is nothing more than window-dressing.

- see the story in Pharma Times
- check out the Pharmalot item
- read the Wall Street Journal article on funding
- get the New York Times editorial

FDA Commish chided over import safety

Wed, 23 Apr 2008 06:59:57 -0400

FDA Commissioner Andy von Eschenbach found himself in the hot seat again at a Congressional hearing. The House Committee on Energy and Commerce grilled the agency chief about foreign oversight and scolded him for safety lapses that occurred on his watch, including the big heparin debacle that's been unfolding since January. "You presided over this," Dingell said.

The committee wasn't happy with von Eschenbach's overhaul plan, either. And they didn't mince words about it. The GAO had appeared at the hearing earlier, estimating that it would cost $16 million to inspect only the Chinese exporters who hadn't yet seen FDA scrutiny, and $67 million to look at exporters worldwide. But when the commissioner skittered around the numbers himself, Dingell accused him of "toe dancing," saying, "I didn't fall off the cabbage wagon yesterday." (Even more colorfully, a Republican committee member from Texas said drug makers need to be held accountable for supply chain problems, "lest we get a bucket of chicken wings with plutonium in them.")

Dingell, you'll recall, released a draft plan for foreign oversight, and this hearing was supposed to gather fodder for the final bill he and his co-sponsors plan to enter. It looks as if the committee got some hard info from the GAO. It also got a few suggestions from von Eschenbach, namely, that FDA needs to hire contractors and/or depend on foreign regulators to certify foreign drug companies. And upon much pressing from Dingell, von Eschenbach coughed up some inspection figures for drugs: 3,000 facilities times $45,000 per, or $70 million on a biennial inspection schedule. How will this change Dingell's bill? We'll have to wait and see.

- see the Chicago Tribune story
- check out the New York Times article
- find a transcript of a few Dingell-von Eschenbach exchanges at In Vivo

FDA chief suspects heparin 'fraud'

Wed, 16 Apr 2008 06:59:55 -0400

The FDA believes Baxter International's recalled heparin was tainted "by virtue of economic fraud," Commissioner Andrew von Eschenbach told a Senate panel yesterday. That heparin has been linked with hundreds of allergic reactions and 62 deaths in the U.S.; some of it contained oversulfated chondroitin sulfate, a contaminant that is chemically similar to heparin's active ingredient but cheaper to make.

After the committee hearing, von Eschenbach backpedaled a bit, saying that the agency doesn't have proof that the drug was deliberately contaminated somewhere along its long supply chain, which includes small workshops and API manufacturers in China. Both Baxter and its API supplier, Scientific Protein Laboratories, say they believe it was tainted before it reached SPL's Chinese processing plant. "One thing you always wonder about is whether it was done in order to be deceptive," von Eschenbach told reporters after the hearing.

Meanwhile, industry experts wonder why a spike in the price of crude heparin didn't raise red flags for drugmakers. SPL says that its costs doubled in the last half of 2007, and it passed some of that increase along to customers. An SPL spokesman said the company attributed that price hike to supply problems and didn't have any safety concerns; the FDA said it didn't see the price increase as a signal of quality problems. But some in the industry say that a sudden spike in prices should have piqued SPL's interest. "I don't know whether anyone could have detected the contaminant early on, but at least they should have been looking," one drug executive said. Hindsight, of course, is apt to pick out red flags like a hawk spies field mice.

- see the article at CNN Money
- check out the Chicago Tribune coverage

ALSO: Real-time drug safety monitoring--like the system proposed yesterday by the FDA--won't lead to a slew of lawsuits and regulatory withdrawals because the data will tell the story, Drug Wonks concludes. Report

Related Articles:
Heparin supply chain full of loopholes. Heparin report
Heparin mimic found in suspect samples. FDA report
Origin labeling a sticky pharma problem. Labeling report
Post-heparin, no oversight excuses. Heparin report

ALSO NOTED: Senate panel offers more FDA funding; Japan OKs Roche's Actemra, Abbott's Humira

Wed, 16 Apr 2008 06:59:50 -0400

> A bipartisan Senate panel agreed that the FDA is "seriously underfunded" and asked Commissioner Andrew von Eschenbach for an estimate of how much more money the agency could use wisely in the coming fiscal year. Report

> Roche' Japanese partner, Chugai Pharmaceutical, got regulators' blessing to sell Actemra as a rheumatoid arthritis therapy in Japan; it's the first big approval for the potential blockbuster. Release

> Japan also cleared Abbott Laboratories' Humira to treat rheumatoid arthritis, the med's first approval in Japan. Release

> Abbott Laboratories reported a 34 percent increase in first-quarter earnings to $938 million on $6.77 billion in sales. Release

> U.K. pharma Shire plans to move its tax base to Ireland to take advantage of its 12.5 percent tax rate on global earnings, rather than Britain's 28 percent. Report

> The FDA gave the nod to GlaxoSmithKline's migraine pill Treximet, a modified version of the soon-to-go-off-patent Imitrex. Release

> Akorn won the FDA's blessing for its Ofoxacin Ophthalmic Solution, a generic anti-infective used to treat conjuncitivitis and other eye infections. Release

> About 26,000 patients are using Tysabri, the multiple sclerosis treatment sold by Elan and Biogen Idec, and the companies have received no reports of a brain infection that prompted the drug's temporary withdrawal in 2005. Report

> Roche snapped up the UK's Piramed today in a $175 million deal that includes a $15 million milestone payment--the latest in a series of new acquisitions. Report

> After a brief period as a high-flying stem cell company, CellCyte Genetics' share price has fallen back to earth, wiping out much of the $440 million market valuation achieved last fall and leaving it in "precarious" financial shape. Report

> NJ Biz examines Genta, which has gone into survival mode as it seeks a way to gain FDA approval of its lead cancer therapy, Genasense. Report

And Finally... A new advance in cloning could lead to designer babies. Report

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

ALSO NOTED: Ranbaxy to produce generic Pfizer drug; Keryx triggers big shakeup;

Tue, 08 Apr 2008 06:59:50 -0400

> The weak dollar and the loss of a key patent depressed Boehringer Ingelheim's full-year results; sales grew 3.6 percent, fed mostly by the 30 percent jump in its lung treatment Spiriva. Report

> Less than a month after seeing its lead drug candidate go down in flames in a late-stage trial, Keryx Biopharmaceuticals announced plans to restructure, chopping its workforce in half as it reduces the company's burn rate. Report

> A high-profile crew of biopharma execs are signing on to help promote the life sciences industry in the UK. Report

> Ranbaxy Laboratories got Japanese regulators' blessing for its generic form of Pfizer's angina and blood-pressure med Norvasc. Report

> Australian women with advanced breast cancer will have cheaper access to the GlaxoSmithKline treatment Tykerb as the national drug program adds it to the formulary. Report

> TPG Capital, a U.S. private equity group, is plowing $800 million into SIA International, a Russian pharma distribution company, in exchange for a 50 percent stake. Report

> A stolen Pfizer laptop contained personal info on 800 employees and contractors, including credit card numbers, addresses, and phone numbers; the burgled computer marks the fifth data breach at the drugmaker since January 2007. Report

> Alzheimer's treatment Aricept may be useful for treating stroke and accident victims, aiding memory and concentration, a small study shows. Report

> Funds from non-profit groups are flowing to biotech R&D. Report

And Finally... The ever-growing blogosphere has a new voice--none other than FDA commissioner Andrew von Eschenbach. Report