Janet Woodcock

Senator calls for outsourcing probe at FDA

Tracy Staton — Tue, 17 Jun 2008 09:54:45 -0400

A new senator is leaping into the pharma fray. Sen. Sherrod Brown, an Ohio Democrat, is calling on the FDA to evaluate its oversight of outsourcing practices. In a letter to the agency, Brown cites a statement by CDER Chief Janet Woodcock at a recent Congressional hearing, when she said some drugmakers outsource their operations because of "lower, less stringent standards in some parts of the world," in addition to lower labor costs. At the same hearing, a Pfizer exec said 17 percent of its active ingredient and drug manufacturing is outsourced--and Brown wants an explanation for that number, too. He wants to know not only how much Pfizer saves through outsourcing, but also what, exactly, has it outsourced to countries with "less stringent oversight?"

It had to happen: Outsourcing has been a hot-button issue, and a highly political one ever since Ross Perot's famous "giant sucking sound" quote when he was running for president. And this is an election year, after all.

- see Brown's release
- read the Pharmalot post

Who are pharma's true VIPs?

Tracy Staton — Fri, 23 May 2008 10:57:38 -0400

You mean you don't know? Helpfully, a trade magazine has ranked them for you. The 40 most influential people in pharma--and they're not always the people you'd expect. In fact, FDA Commissioner Andy von Eschenbach didn't make the list. Who did? Carl Icahn, for one. The highest ranking CEO was (drum roll, please) Genentech's Arthur Levinson at the number two spot. GlaxoSmithKline's new CEO Andrew Witty came in came in at number six. Other familiar names include Bill and Melinda Gates (3), Janet Woodcock (18), Warren Buffett (25)and J. Craig Venter (27). You'll have to read the list to get the rest.

- check out the list and article in World Pharmaceuticals (.pdf)
- see the Pharmalot item

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

Public Citizen joins FDA review

Tue, 13 May 2008 06:59:57 -0400

When Cephalon asked the FDA to expand the use of its opioid painkiller Fentora, did it see the shape of things to come at the agency? In Vivo says yes, the "challenging" regulatory environment was on display during last week's advisory committee meeting. In fact, the drugmaker may have faced the embodiment of FDA's apparent caution: Sidney Wolfe, M.D., of the consumer group Public Citizen, a frequent pharma critic, was a "temporary voting member" of the committee hearing the Fentora request.

Agency observers tell In Vivo that Wolfe will be at that table more often in the months to come--and the blog thinks that's a good thing, now that FDA has more post-marketing enforcement tools at its disposal, because Wolfe will push the agency "to use its new tools aggressively." Plus, his presence would be an added stamp of credibility: "If his opinions are built into the standard risk management reviews, then his concurrence should shield the agency (and drug sponsors) from further criticism." We'll be watching this one closely.

- see the item at In Vivo

ALSO: "New" CDER chief Janet Woodcock has been busy weighing in on risk-management plans, too--and trying to figure out how to implement other measures of the FDA Amendments Act, too. Report

FDA backpedals on inspection funding

Fri, 02 May 2008 06:59:58 -0400

Now you see it, now you don't. Congress thought--or pretended to think, you never know on Capitol Hill--that the FDA had ball-parked the funding it needs to beef up foreign inspections. That would be $225 million, a number contributed by CDER chief Janet Woodcock on Wednesday. But Thursday at a hearing of the House Energy and Commerce Committee, Woodcock backed away from that figure, saying that the agency does need more resources, but the Bush administration had to say how much.

Woodcock also declined to support the lawmakers' proposed legislation, which would boost inspections and enforcement powers in an attempt to prevent contaminated drugs from slipping into the U.S. Mandating foreign facility inspections every two years isn't a good idea, she added, saying that the FDA should decide which plants to check out, based on risk assessment.

Neither would Woodcock support user fees as a funding mechanism for inspections. But industry types who testified at the same hearing said they're open to those fees--within limits. And the industry wants assurances that inspections will focus on "high-risk" foreign manufacturers.

Consumer advocates are also OK with user fees, but also within limits. Drugmakers shouldn't use the fees as a way to "exert undue influence over FDA," Consumers Union said. Some advocates say the industry already has too much sway over the agency because of user fees that finance the approval process.

- see the user-fee article in the Star-Ledger
- read the Wall Street Journal story

FDA wants power to police imports

Wed, 30 Apr 2008 06:59:57 -0400

The FDA finally put its mouth where the money is. During congressional hearings yesterday, CDER chief Janet Woodcock said the agency would need $225 million to $250 million in additional funding to inspect foreign plants as frequently as it does in the U.S. And, along with drug compliance director Deborah Autor, Woodcock asked Congress for the power to inspect foreign companies that ship drugs to the U.S., stop imports at the border if necessary, and require U.S. drugmakers to police their foreign suppliers.

"We currently have a crisis and an opportunity to make real change," Autor said.

The requests came during hearings into the heparin-contamination scandal. The blood thinner has been linked to 81 deaths and 785 allergic reactions. In written testimony, Woodcock reiterated the FDA's suspicion that the med was deliberately tainted with oversulfated chondroitin somewhere along the Chinese supply chain. Some batches of the Baxter med consisted of more than 30 percent of the contaminant, "and it does strain one's credulity to suggest that might have been done accidentally," Woodcock said.

Congressional investigator David Nelson, who's leading the heparin inquiry, criticized the FDA for failing to inspect the Chinese plant operated by Baxter's API supplier. But Nelson reserved his most pointed critique for Baxter, saying that the company hadn't adequately inspected that plant, either. For his part, Baxter CEO Robert Parkinson called import oversight problems "a global and industry-wide crisis."

- read the Los Angeles Times story
- see the New York Times coverage
- check out Parkinson's remarks at CNN Money

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 to piggyback on insurers' databases

Tue, 15 Apr 2008 06:59:55 -0400

Remember that drug-safety database Congress required the FDA to set up? The idea was for the FDA to actively monitor drugs and possible adverse effects, rather than waiting for doctors and drug companies to report problems. Well, the agency is ready to announce its plans--and they don't include setting up a database. Instead, the FDA will contract with insurers, such as WellPoint and UnitedHealth, to scan their members' records for potential problems. The agency also plans to bring other health systems into the effort.

"We're bringing together all these different groups in a network so that we can ask them to look at the same question at the same time," Janet Woodcock (photo), CDER director, told the Wall Street Journal.

The FDA will use the databases to monitor potential problems that showed up in a less-than-statistically-significant way during clinical trials. The insurers and other network participants also will build computer models to detect signals of potential problems that weren't suspected before. To show that it could do so, WellPoint tested its 1999 data and found that it could have spotted the heart-related problems associated with Vioxx within four months of the drug's introduction.

- read the WSJ story

Related Articles:
Bickering may stall trial database. Report
Senate toughens drug safety supervision in PDUFA bill. PDUFA report
PDUFA debate highlights drug safety issues. PDUFA report
FDA taps new-yet-old drug chief. FDA report

Woodcock: FDA wary of Vytorin debate

Wed, 09 Apr 2008 06:59:56 -0400

Expect the FDA to stay out of the Vytorin fray, at least for now. So Janet Woodcock (photo), CDER chief, told FDAWeb in an interview (recounted, in turn, by Pharmalot). The agency is afraid of seeming "defensive" if it weighs in now. But Woodcock did make clear that FDA still considers lowering "bad" cholesterol--which Vytorin did quite well in the Enhance study--to be a valid surrogate for heart-disease prevention.

Scientific nitpicking about LDL is misleading people, Woodcock said: "[T]here is some little point that the scientists are arguing about, and then the media get on it, and they start throwing the baby out with the bathwater," she said. "...[but if] people think we're just being defensive, we wouldn't make a difference in this environment."

Meanwhile, new data is in on the expected drop-off in Vytorin and Zetia scrips. A Deutsche Bank analyst surveyed primary care docs and found that 75 percent expect usage of both drugs will drop in their practices. The analyst now predicts that market share for Vytorin will drop to 9 percent from 16 percent. Zetia, one of the drugs in the Vytorin combo, will see its share drop to 6 percent from 9.5 percent, the analyst concluded.

Some of that drop-off will be in new scrips, some from patients switching. In an investor note, the analyst predicted "increased utilization of other statins, especially [Pfizer's] Crestor."

- see the Woodcock interview excerpt at Pharmalot
- check out the scrip numbers
- see Pharmalot's analysis of Deutsche Bank's predictions

Related Articles:
FDA's Woodcock handed back the reins at CDER
FDA chief: Woodcock is a 'change agent'
UnitedHealth stands by Vytorin
Insurers, PBMs mull Vytorin data.
Congress: Merck, Schering-Plough sat on bad news
ACC panel unleashes Vytorin whirlwind