October 26

At FDA, Changes In Name Only–Agency Puts Business interests Above Safety

At FDA, Changes In Name Only–Agency Puts Business interests Above Safety

Fri, 30 Sep 2005

The sudden resignation of FDA Commissioner, Lester Crawford, after just two months in office, has prompted a bipartisan Senate investigation and requests both by the Senate committee HELP and by congressman Maurice Hinchey (NY) and five other members of the House to request an investigation by the Inspector General. The New York Times reported yesterday that Dr. Crawford may have failed to disclose financial holdings in companies overseen by the FDA.

From all appearances – such as the appointment of Sheldon Bradshaw to replace Daniel Troy as Chief Counsel, and the President’s choice of a part-time acting commissioner to replace Crawford – nothing in the agency’s culture has changed. Business interests supersede any cosmetic gestures meant to assuage the public about increased attention toward safety.

It is instructive to compare and contrast a report by Gardiner Harris in The New York Times with one in the Legal Times assessing what changes have actually taken place at the FDA since the spate of drug safety scandals that revealed the agency turning a blind eye to the mounting casualties resulting form lethal drug effects .

On August 6, Harris portrayed the changes – such as label warnings – through the prism of FDA officials who consistently side with industry, not drug safety. Dr. Scott Gottlieb, for example planted the view that the agency’s advisory committees "are vulnerable to a growing chorus of criticism," implying they are not persuaded by evidence. He then planted the insidious suggestion (which Harris dutifully reported as fact): "Now, instead of waiting for proof, the agency has promised to issue public health alerts about drug risks even when problems are only suspected. And over the last year, it has demanded that pharmaceutical companies add tough warnings for drugs as diverse as the antidepressant Zoloft, because it might lead a small number of teenagers to become suicidal, and the popular pain pill Advil, because it might in rare cases cause heart attacks. ”

Gardiner Harris was badly misled by FDA officials whose concern is clearly with business interests when he wrote that proof was needed. In point of fact ,  the Food Drug and Cosmetics Act (21 CFR 201.57(e) ) REQUIRES warnings when there is reason to suspect a hazard: "the labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved."

Before the FDA came under the undue sway of industry a single defective can  of tuna fish that caused food poisoning would trigger a recall. How then can the Times trivialize the suicide of "a small number of teenagers" and preventable heart attacks linked to an analgesiac?

Representative Maurice D. Hinchey of New York put the issue in perspective when, referring to FDA’s inaction in the face of the Vioxx tragedy, said: “When F.D.A. goes through a 14-month-long period to get a labeling change that both it and its panel of experts agrees is necessary, that shows us that something is wrong.”

The Legal Times reports (September 19) that the legacy of Daniel Troy who, as FDA’s Chief Counsel, intervened in civil court cases on behalf of companies such as Pfizer, continues to be followed by the agency’s new Counsel, Sheldon Bradshaw. And an analysis of the number of compliance and warning letters shows that fewer  such letters have been issued –even as the number of corporate violations increased. So public posturing notwithstanding, in terms of policy, nothing has changed  at the agency–business interests take priority over safety.

Contact: Vera Hassner Sharav

Senate Panel Opens Inquiry on F.D.A. Chief’s Resignation
By Robert Pear: September 30, 2005

WASHINGTON, Sept. 29 – A Senate committee said Thursday that it had opened a bipartisan investigation of the reasons for the sudden resignation of Lester M. Crawford as commissioner of food and drugs. The panel said it wanted to determine if Dr. Crawford had complied with federal ethics laws and if his financial disclosure statements had been accurate. The same Senate committee recommended confirmation of Dr. Crawford in June.

The committee chairman, Senator Michael B. Enzi, Republican of Wyoming, and the senior Democrat on the panel, Senator Edward M. Kennedy of Massachusetts, they were examining why Dr. Crawford resigned abruptly on Friday, with no explanation, just two months after he was confirmed by the Senate. Mr. Enzi and Mr. Kennedy asked for help from the new inspector general at the Department of Health and Human Services, Daniel R. Levinson. In a letter on Thursday, the senators said they were “examining the circumstances surrounding” Dr. Crawford’s departure, and they asked Mr. Levinson to “conduct a thorough review of the reasons” for his resignation. “Specifically,” they wrote, “we would appreciate if you would examine his financial reporting in accordance with the various ethics laws to determine whether he was in compliance and whether he was forthcoming in his attestations to the White House counsel, the Department of Health and Human Services, the Office of Government Ethics and the committee.” Xxxxx cut xxxxx

THE NEW YORK TIMES : F.D.A. Responds to Criticism With New Caution By GARDINER HARRIS    August 6, 2005 

Stung by a series of drug safety scandals, the Food and Drug Administration has in recent months issued a blizzard of drug-safety warnings and approval times for new drugs are slower. The agency is issuing twice the number of public advisories about drug risks as it did a year ago and adding five times as many black box warnings – its most serious alert – to drug labels. And drugs approved in the first half of this year took almost twice as long to get that approval as drugs approved in the same period last year. This new conservatism, a response to fierce recent criticism from Congress that the F.D.A. has failed to protect the public against drug dangers, has upset some doctors and drug makers.

Doctors say that the agency’s vague warnings and confusing advice mean that doctors are not getting the information they need to avoid problems but will get blamed for them anyway. Drug makers say the warnings are scaring patients and reducing sales. The apparent changes have done little to mollify the F.D.A.’s many critics, who say that the agency is either not doing enough, doing too much or failing to be consistent. “The F.D.A. should not be slowing things down or speeding them up depending on how the wind blows,” said Senator Charles E. Grassley, a powerful Iowa Republican who has become one of the agency’s toughest critics. “Instead, the agency should be a rock of stability.”

F.D.A. officials dismissed the notion that the agency has changed the way it regulates drugs. “Maybe we’re not being overly cautious but instead trying to be responsive,” said Dr. Scott Gottlieb, the agency’s deputy commissioner. But Dr. Gottlieb said that the agency’s advisory committees – crucial arbiters of drug risks – are vulnerable to a growing chorus of criticism. If the advisory committees become more cautious, he said, the F.D.A. might follow their lead. The agency once avoided issuing disturbing warnings about drugs unless studies proved that a risk was certain. Agency officials had worried that issuing warnings about suspected problems would cause undue alarm and lead patients to stop taking needed therapies.

But two episodes over the last year – one involving antidepressants and suicide risk and the other the withdrawal of the pain pill Vioxx – have led the agency to become more cautious. Now, instead of waiting for proof, the agency has promised to issue public health alerts about drug risks even when problems are only suspected. And over the last year, it has demanded that pharmaceutical companies add tough warnings for drugs as diverse as the antidepressant Zoloft, because it might lead a small number of teenagers to become suicidal, and the popular pain pill Advil, because it might in rare cases cause heart attacks.

In each case, according to disclosures at open hearings, the agency has acted with little or no evidence that the risks are real. But it has demanded that warnings be placed on them anyway. In many cases, patients have stopped taking the medicines in the wake of the warnings. “Drug reviewers have seen that the environment has changed, and they’ve become more cautious because they don’t want to be the next person hauled before Congress,” said Dr. Kenneth I. Kaitin, director of the Tufts Center for Study of Drug Development.

Agency officials say that they are simply trying to do a better job of communicating drug risks directly to doctors, pharmacists and patients after years of letting drug makers do most of the talking. The agency will soon issue instructions to drug companies about how to send information by e-mail directly to physicians about drug risks, Dr. Gottlieb said.Dr. Lester Crawford, who last month was confirmed by the Senate to become the Food and Drug Administration commissioner, has said that the agency can no longer wait until risk information is proved but must communicate its uncertainty to the public. This has left many physicians uneasy “They’re just passing the blame onto the physician if something goes wrong,” said Dr. Phillip Kennedy, a family-practice physician in Augusta, Ga. “They’re just trying to say that they warned us.” Vague warnings about uncertain risks are difficult for doctors to interpret, Dr. Kennedy said.

Dr. William Schreiber, an internist from Louisville, Ky., said that the agency’s murky and sometimes contradictory messages have hurt its credibility. “Many of us depend on that agency to tell us that a drug is O.K.,” Dr. Schreiber said. “And when they miss the risks for a whole category of significant drugs – and I’m still not sure whether they’re right – it makes you question the linchpins of the system.”

The problem is that the F.D.A. is often uncertain about how important a potential problem with a drug might be, Dr. Kaiten said. “So, more often than not, they just don’t know what to tell physicians and patients,” Dr. Kaiten said. When it is unsure, the agency often advises patients to speak with their doctors, Dr. Kaiten said, “but the physicians don’t know what to tell patients, either.” Dr. Jeremy A. Lazarus, vice speaker of the House of Delegates of the American Medical Association, said that there is a solution. “We think there have to be better studies done that are adequately designed and long enough to answer these questions,” he said.

So far this year, the F.D.A. has issued 11 public health advisories about drug risks compared with five in all of last year and two in 2003. In the first half of 2005, the agency placed black-box warnings – its most serious alert – on the labels of 45 drugs compared to just 9 during a similar period last year. The agency is also taking more time to review new drug applications. For drugs approved in the first half of 2005, the average time from application to approval was 29 months, compared with an average of 16 months for drugs approved in the first half of 2004. And the F.D.A. is more often asking that drug makers study the safety of their medicines after they are approved.

Dr. Gottlieb explained that much of the recent increase in the number of black-box warnings is due to the agency’s decisions to place the warnings on 33 antidepressants. He said that because the agency processes so few new drug applications, average approval times can change substantially from year to year because of a single difficult application.

The agency’s growing caution has drawn muted praise and scorn from critics. Dr. Sidney Wolfe of Public Citizen said that the agency still is not cautious enough. Dr. Jerry Avorn, a professor of medicine at Harvard Medical School who for years criticized what he saw as a lack of caution at the F.D.A., said that the agency has overreacted. “They went from comatose to spastic without any rational period in the middle,” Dr. Avorn said. Jack Calfee, a resident scholar at the American Enterprise Institute who has long criticized the agency for being overly cautious, said that its latest actions are an unfortunate but understandable reaction to fierce public criticism. “It would be amazing if they did not become more cautious in the wake of the Vioxx episode,” Mr. Calfee said. Merck, the maker of the painkiller Vioxx, withdrew the drug from the market in September after a study found that it doubled the risks of heart attack and stroke. The Vioxx withdrawal has been a driving force for some of the changes at the agency. Critics in Congress pointed out in hearings that the F.D.A. negotiated with Merck for 14 months in 2001 and 2002 before any substantial mention of Vioxx’s heart risks appeared on the drug’s label.

“When F.D.A. goes through a 14-month-long period to get a labeling change that both it and its panel of experts agrees is necessary, that shows us that something is wrong,” Representative Maurice D. Hinchey, Democrat of New York, said in a hearing last week. Dr. Steven Galson, director of the agency’s center for drugs, answered Mr. Hinchey, “We’re not proud of how long that took, let me just be clear about that.”

The F.D.A. does not own a drug’s label, drug makers do. Short of threatening to seize a drug if a label is not changed, the agency must negotiate with drug makers over any changes. This can lead to delays. Some in Congress have proposed giving the agency the power to mandate label changes, but Dr. Crawford said that the Bush administration has no position on these proposalsŠ. Xxx cutŠ.xxxx 

Copyright 2005 The New York Times Company

Legal Times: 
At FDA, Change In Name Only; Legal Business;
New counsel keeps industry-friendly policies put in place by his predecessor    
By Lily Henning 
19 September 2005– p. 1

Sheldon Bradshaw arrived at the Food and Drug Administration without the baggage lugged around by his predecessor. The previous chief counsel at the FDA, Daniel Troy, was pilloried by critics who slammed his close ties to the drug industry. Troy made a name for himself suing the agency on behalf of drug and tobacco companies before moving to the government agency early in the Bush administration. Bradshaw, who came to the FDA as chief counsel from the Justice Department in April, has escaped that kind of scrutiny, largely because he hasn’t had those corporate relationships. But that doesn’t necessarily mean a new day has dawned.

In fact, despite Troy’s return to the private sector, his controversial legal policies remain in force at the agency. Like Troy, Bradshaw offers one-on-one meetings with the companies regulated by the agency, has kept low the number of warnings issued to companies violating regulations, and, perhaps most notably, has continued to intervene on behalf of drug companies in private civil lawsuits.

Last week, Bradshaw signed off on a brief agreeing with Pfizer Inc.’s claim that three years ago the FDA would not have allowed the drug company to warn consumers about a link between suicidal behavior and the use of its best-selling antidepressant, Zoloft, by adolescents, an argument Pfizer is using to ward off liability.

That approach and a lighter regulatory hand put the public at risk, consumer and public health advocates complain. And even some in the drug and medical-device industries find the regulatory regime under Troy, and now Bradshaw, discomforting, claiming that without strong FDA oversight, companies are being hauled into court more frequently by state attorneys general and private plaintiffs.

“One of our clients said to me a few months ago, ‘I miss the FDA,'” says Arnold & Porter’s Donald Beers, a food and drug attorney who served as associate chief counsel for drugs and for enforcement in the FDA’s Office of Chief Counsel between 1975 and 1985. “An aggressive FDA that occupies the stage is sometimes better than having lots of different people sniping at you.”


Before joining the FDA in April, Bradshaw was principal deputy assistant attorney general in the Department of Justice’s Civil Rights Division. Bradshaw’s move to the FDA — generally considered a less prestigious agency for government lawyers than the Justice Department — surprised some of his former colleagues, who describe him as being part of an ideologically conservative group of young leaders in deputy positions at the DOJ. He also worked in the Office of Legal Counsel, made up of an elite group of lawyers at Justice who advise the executive branch. Among the office’s alumni is Troy. Both he and Bradshaw were part of the Bush administration’s advance legal teams in 2001. Bradshaw says that his lack of experience in the food and drug regulatory arena could be, in the wake of what he says was unfair criticism of Troy, a good thing. “I think it’s helped me in my transition that I wasn’t seen as already having made up my mind on certain issues,” Bradshaw says. “There isn’t a perception that I would have a preference in any given case.”

But those looking for changes to policies initiated under Troy will be disappointed. Bradshaw says he has no intention of changing the way the FDA’s legal department does business. That continuity was evident last Thursday, when the government filed an amicus brief in Utah reiterating the argument championed by Troy that the FDA’s jurisdiction over prescription-drug labeling prevents plaintiffs from suing Pfizer over Zoloft’s lack of a warning label. “Wherever I go, people ask me if I am going to continue Troy’s policy in pre-emption cases,” Bradshaw says, adding that the FDA does not take such action by itself and must have consent from the Department of Justice and the political leadership at the Department of Health and Human Services.

Troy was a pioneer of the government’s intervention on behalf of Pfizer in cases related to Zoloft and suicide, contending the FDA would not have permitted Pfizer to warn about the suicide risk because there was not enough scientific support for the warning. The government’s involvement began in September 2002, when Justice, joined by the FDA, filed a friend of the court brief in the U.S. Court of Appeals for the 9th Circuit case Motus v. Pfizer. (The 9th Circuit, however, ultimately decided the case on different grounds, never reaching the pre-emption issue.)

The argument was based on the premise that since the FDA has sole jurisdiction over the labeling process of prescription drugs, drug companies like Pfizer should not be held liable for warnings on products if they follow FDA requirements.

The FDA’s involvement in the Pfizer case sparked indignation among interest groups, which complained that Troy, who had represented Pfizer in private practice, was leaping to the defense of industry. Plaintiffs advocates complain that if the FDA’s legal argument in the Zoloft case is applied broadly, then victims won’t be able to sue if they are injured by any FDA-regulated product. Pfizer has used the 2002 brief for the past three years to fend off lawsuits involving Zoloft-related suicides.

In June, Judge Paul Cassell of the U.S. District Court for the District of Utah asked the government to weigh in again, noting that the FDA’s opinion was important because the agency had injected itself into the debate with the 2002 brief.

In that case — the first in which the government has intervened since Bradshaw took over — the family of 15-year-old Shyra Kallas sued Pfizer, claiming that Zoloft’s label at the time their daughter committed suicide in 2002 did not disclose the risks of suicide and suicide-related side effects associated with the use of Zoloft in adolescents. They also claim Pfizer failed to warn Kallas’ doctor of that possibility. Kallas, who was prescribed Zoloft by her primary-care doctor, shot and killed herself a month after starting on the drug. Cassell asked the FDA to explain whether the 2002 brief would apply to the Kallas case, noting that the case involves a minor. The drug is not approved for treatment of depression in adolescents. And while Bradshaw calls the circumstances of the Kallas case “tragic,” last week’s filing didn’t alter the position the government held under Troy.

Judges have had mixed responses to the FDA’s position on the Zoloft cases, of which there are now more than a dozen nationwide. In a March 2005 decision in a federal court in Texas, in which Pfizer had filed the 2002 amicus brief, Judge William Steger wrote that Pfizer had relied heavily on the FDA to support its arguments. But the judge ruled that evidence before the agency did suggest that a warning about suicide risks was appropriate and that the FDA’s regulations do indeed allow a manufacturer to add to or strengthen a warning without prior agency approval.

Karen Menzies, who represents plaintiffs in cases related to Zoloft, notes that Pfizer never asked the FDA if it could warn consumers about the suicide risk, adding that the FDA had information about the suicide risk associated with antidepressants like Zoloft since the early 1990s but did not analyze it.

The contention that the agency would have prevented Pfizer from issuing the warning is “pure speculation by the FDA’s attorneys,” says Menzies, a partner with Baum Hedlund in Los Angeles. “But the sheer weight of the FDA intervening is very persuasive.” Pfizer has consistently denied any link between suicidal behavior and the use of Zoloft by adolescents. Last fall, after a review of studies on risks of suicidal thoughts and behaviors in children taking antidepressants, the FDA directed manufacturers to add a “black box” warning — the most severe kind of advisory — to the medications’ labels to emphasize the need for close monitoring of child patients taking those drugs.


Troy, 45, is, for many critics of the Bush administration’s FDA, Exhibit A of the dangers of appointing a regulator who clashed with the very agency in which he would later play a pivotal role. The first appointment to the FDA made by President George W. Bush, Troy says his was a necessarily high-profile role. As chief counsel, he gave nearly 80 speeches and met with dozens of industry groups.

Troy says the meetings sometimes helped to narrow the scope of litigation against the agency and, in some situations, to avoid it. “Sometimes when they heard our side, they said that’s a good point — or we’re not going to beat you in court,” Troy says. “Sometimes I ended up hearing their tale and decided that we were wrong.”

Troy was slammed by a wide range of detractors, from newspaper editorial writers to Capitol Hill legislators, for what they said were brazen actions benefiting the industries he represented in private practice. Šxxx cut ..xxx

Copyright 2005 ALM Properties, Inc. All Rights Reserved.

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