Latest Drugwonks' Blog
And you would have missed this penultimate statement from the flurry of memos (I read them all)
"I agree with the idea that we should preempt state requirements for labeling of drugs. It makes no sense for us not to have a federal system for labeling approved drugs that is based on a careful scientific review of the available data and a consistent application of labeling policies across products. I see this as a legitimate FDA area of involvement given our statutory authority over the drug approval process."
That was John Jenkins. And not one of the memos take issue with the position that FDA should preempt state requirements, especially those dredged up from tort proceedings.
The issue was and is about whether the FDA had enough control over labeling and safety monitoring in a coordinated fashion to produce the appropriate balance between risk and benefit, patient rights and company behavior. The goal is to encourage companies to do more to make sure labeling reflects the most up to date science and is communicated clearly and quickly to patients and everyone else to improve the use of the product and public health. The idea that FDA officials and their words are being twisted to promote a trial attorney agenda is disgusting beyond imagination...
Jenkins seeks a compromise which is now part of the fabric of the Critical Path and FDA authority under FDAAA:
"If we are going to go this route to protect sponsors, the appropriate balance in the favor of public health may be to give FDA more authority over labeling."
Which is exactly what has happened since 2003 when the memos were written. Where oh where have the self-serving solons at JAMA and NEJM been the past five years. They keep flogging VIoxx as an example of why tort lawyers should have control over labeoling. But within the FDA Vioxx was and is regarded as a safe drug under certain conditions that no longer apply since the drug was withdrawn:
Jenkins again:
"Had Merck not decided to voluntarily withdraw the product it would have been necessary for them to make labeling changes to add warnings about ,the new findings. We probably would not have issued an approval letter on the labeling changes since we would not have had access to the full study report for review so we could evaluate the actual data that would be added to the labeling. So, we probably would have agreed to interim labeling and asked Merck to submit it as a CBE and we would have made more official determinations later after we reviewed the full study report. "
It was the withdrawal of Vioxx and the failure to work with the FDA to make labeling changes that triggered the "Vioxx scandal" and the ensuing mess. Waxman wants us to believe FDA officials want more of the same instead of a science-based approach to label changes.. The Waxman report is all about manipulating the truth and is an example of how "facts" are treated in the courts that he and others would want to determine what is said about medicine and how it's practiced.
I am still colelcting my notes and my thoughts and will report on what the various speakers (including the FDA's Janet Woodcock, Jane Axelrad) had to say. In the meantime, let me commence this reportage with my own opening remarks:
When I told my wife -- who is not in this line of work -- that I was chairing a conference on REMS, she asked me what I was doing at an event about rapid eye movement.
A common question I get about REMS is – how is it different from what we used to call RiskMAPS? I see two main differences. The first, obviously and importantly, is that REMS has actual legislative language. And that’s an important detail – but it’s one-dimensional.
While I agree that REMS does indeed represent an expansion of the FDA's authority, I do not agree that it is either ill advised or an over-extension of the agency’s purview.
Their latest attempt to muddy the waters of FDA labeling authority comes in the form of internal FDA documents that, Waxman staffers claim, show career officials oppose agency regulations that weaken consumers' ability to sue drug makers.
Here’s one quote they’re using to make the case for “the FDA doesn’t believe in preemption" ...
"Much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis," the report quoted Dr. John Jenkins, who oversees FDA's new drug reviews, as saying. "We know that such an assumption is false."
Nobody ever claimed that any FDA label is fully accurate. Such an assumption is indeed false – but nobody has ever said different. What supporters of preemption do say is that the FDA carefully considers the scientific evidence relating to any proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. Those who support preemption believe that a drug’s FDA mandated label deserves deference from courts and juries applying state tort law.
John Jenkins is right. But that doesn’t make preemption wrong.
The next “smoking gun” statement comes via Jane Axelrad, an associate director for policy at the agency, who wrote: "We rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary," she said. "To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information."
Jane’s right too. But that doesn’t change the argument for preemption. Of course drug companies would prefer to minimize risk information – and they make their arguments based on sound science. Sometimes the FDA agrees, other times they do not.
Labeling can and must be a valuable tool for improving and protecting America’s health. That’s the law. The FDA is concerned that current labeling practices are in direct counterpoint to the principle objective of current regulations, to facilitate a doctor’s ability to “rationally prescribe” any medical product approved by the FDA. Rational prescribing occurs when a health care professional orders an approved prescription drug or biological product in circumstances where the risk/benefit profile of the product is optimal. The FDA’s most potent weapon in the battle for accurate, timely, “rational,” prescribing is clear, approved labeling.
The FDA’s legal and legislative authority over labeling for prescription drugs and biological products is plenary. The Federal Food, Drug, and Cosmetic Act establishes mandatory and prohibited labeling content and manufacturers have no choice but to comply with these requirements. Less obvious, but equally important, is the principle that the Act also constitutes a “ceiling.” In other words, a manufacturer cannot add risk information to labeling unless the FDA has specifically granted its permission.
The FD&C Act clearly gives the FDA the authority to decide whether or not a product, when used properly, is safe, effective, and properly labeled. A product, used as described in FDA-approved labeling, should be considered safe and effective throughout the United States. Preemption is a well-recognized doctrine of constitutional law derived from the Supremacy Clause and analyzed by the Supreme Court in several cases. Federal law preempts state law here because FDA intends for federal regulation to be exclusive and preemption does not exceed statutory or constitutional limitations.
The “leaked” documents being aggressively peddled to the media change the sound legal and public health argument for preemption not a whit. What it does show is that there is a robust and collegial debate within the agency on this matter. Taking these conversations out of context, as is now being done by members of Mr. Waxman’s staff, just shows how desperate they are – and how weak their intellectual arguments.
"Honest differences are often a healthy sign of progress. "
-- Mahatma Gandhi
But – and it’s a big but -- NICE, the National Institute of Clinical Excellence, is expected to introduce a big increase in the threshold to assess whether such treatments for relatively rare conditions are cost-effective.
In other words, NICE is going to even further restrict access to critical care – particularly for cancer patients.
Alan Johnson, the health secretary, told the Daily Telegraph at the weekend he wants "a fair system that doesn't deny people essential treatment unduly.”
Welcome to “benevolent government healthcare.”
What's troubling is that Cong. Carolyn Maloney wants to do randomized trials to compare autism rates between groups of kids vaccinated with thimerosal preserved shots compared to those without.
Of course this is the handiwork of David Kirby and other anti-vaccine freaks who know they can tease out of any data the slightest link and build their case in court. The scientific community should say "no" to this pseudo-experiment.
http://invivoblog.blogspot.com/
Lest anyone forget, Light tried to pass himself off as an adviser to President Bush in powerpoint presentations he made in support of price controls and drug importation by virtue of becoming an on-line member of some Republican donor's circle.
Here's the story of LIght's slimeballing, his willful spreading of a lie and how on-line members of the unhinged anti-pharma army ran with the rumor that Light's personal attack was being "silenced."
Read more here
If you visited the Web site of the student-run Harvard Health Policy Review last week, you would be greeted with the words "Access forbidden!"
On Monday, rumors soon began circulating on the pharmaceutical blogs Pharmagossip and Gooznews that a higher authority had pulled the plug on access after the journal published a scathing attack in September on three Harvard professors who edit the Journal of Health Economics and serve as faculty advisors to the Review.
Not true, Review editor-in-chief Kevin Huang told The Scientist. While the dispute led one Harvard economist, Richard Frank, to resign from the journal's advisory board, the decision to temporarily take the Web site down was made by student editors. "When the article broke," says Huang, "I really had no idea what was going on." The article had been handled by a senior editor, and he wanted read it and discuss it with the group. "Now, when I look at the situation, it was really one-sided, and as a journal, we do want to be balanced." (The Review is not peer-reviewed.)
The disputed article, "Ethical Standards for Healthcare Journal Editors: A Case Report and Recommendations," was written by Donald Light of the University of Medicine & Dentistry of New Jersey and Rebecca Warburton of the University of Victoria. It vividly describes their frustration trying to publish a critique of a 2003 estimate of drug development costs in the Journal of Health Economics.
That estimate, published in the JHE by Joseph DiMasi at the Tufts Center for the Study of Drug Development and two colleagues, put the price for bringing a new drug to market at $802 million. But Light and Warburton wanted to argue that DiMasi's team had worked off of pharmaceutical funding since the mid-1970s. Plus, they believed the team relied upon unverifiable data, and made questionable assumptions. Instead of publishing their letter, Light and Warburton allege, JHE editors defanged their critique and were overly generous with space granted for the original authors' response. Light and Warburton demanded an additional rejoinder, and only achieved their goals after threat of legal action. "The editors of JHE violated, in our opinion, almost every ethical standard established for editors," they write, "Yet they remain accountable to no one."
Light told The Scientist he chose to vent his tale in the Review because "It seemed like an interesting journal and it was on their own turf." He felt his sharply worded critique was important because "The DiMasi results continue to be cited by journalists, policy-makers, congressional bills, and by reports by the Department of Commerce protecting the American market from lower drug prices in other countries."
JHE editor Thomas McGuire told The Scientist that Light and Warburton's accusations are "far-fetched" and "bullshit," and says he was initially glad to accept the Light and Warburton article but wanted to scrub it of "personal attacks" against DiMasi.
A major point of contention sprang from the journal's standard policy for handling conflicts-of-interest: Although the Tufts Center is openly funded with drug money, authors only need to disclose direct sources of project funding. McGuire felt that questioning DiMasi's "motives" and emphasizing this potential conflict was unfair in light of the journal policy. "[Light] has been quite personal in his attacks on the original authors and on me, and it was clear he was on a mission here," said McGuire, who does not accept money from drug companies.
Light also asserted that McGuire gave DiMasi et al the "last word." But McGuire contended that is standard practice when authors respond to a published study.
Even so, JHE editors felt that many of Light's claims were reasonable. The assertion that the drug data are unverifiable, for instance, had been noted by editor Richard Frank in an editorial that accompanied the original DiMasi et al paper. "I think there are some real conflicts-of-interest out there," Frank said, "I don't have a problem with trying to insist on disclosure." He added that he also made cuts to the DiMasi reply that he felt were personal.
The JHE editors are in discussion with the Review about publishing a reply or posting their response online.
As for Light, he appears to be spreading the Harvard censorship rumor. In an October 18th email sent to a colleague and obtained by The Scientist,Light wrote, "Someone, it seems -- the Harvard University Administration? -- has decided to protect its three full professors who censored critics of the pharmaceutical industry by blocking out all access to the case and the evidence."
This morning (October 21), the Review posted a more heartening message on its Web site: "We have taken down our website temporarily to update it. We hope to have it up very shortly."
--Brendan Borrell
mail@the-scientist.com
Correction (October 22): In the original version of this story, we incorrectly referred to Merrill Goozner's blog as Goozner News. The blog's true name is Gooznews. The Scientist regrets the error.
Read New York Times Article here
In today’s Wall Street Journal, reporter Alicia Mundy begins her article on Wyeth v. Levine as follows:
And here’s former FDA Chief Counsel Dan Troy’s opinion:
“Judgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDA’s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agency’s scientific determinations. FDA’s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency’s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.”
It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations – so any mention of “the Bush FDA pushing preemption” is just bad reporting.
Recently, the 3rd U.S. Circuit Court of Appeals ruled that federal law bars a suit alleging false-advertising claims under state law because the U.S. Food and Drug Administration has "exclusive authority" to regulate prescription drug advertising.
"To allow generalized state consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose an undue obstacle to both Congress' and the FDA's objectives in protecting the nation's prescription drug users," U.S. Circuit Judge D. Brooks Smith of the Western District of Pennsylvania, wrote in his 51-page opinion in Pennsylvania Employees Benefit Trust Fund, et al. v. Zeneca Inc.
Further, U.S. Solicitor General Paul Clement issues an opinion to the U.S. Supreme Court supporting federal preemption, saying that FDA-approved drug labeling preempts state law.
Specifically, Clement disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, “erroneously interpreted” the law by saying the FDA’s approval of a drug label is only a “first step.” He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.
Clement writes, “If manufacturers were free to make unilateral changes to labeling the day after the FDA’s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agency’s careful balance of risks and benefits thwarted.
Press candidates on electronic medical records
Adopting health information technology will require the knowledge and resources of both the public and private sectors. But health IT will usher in a new era of medicine, improving communication among physicians, helping doctors discover health problems before they grow severe, and allowing medical staff to come up with personalized treatment options. Reforms like this hold enormous potential for reducing healthcare costs and improving the quality of life for millions of Americans without sacrificing valuable programs such as Medicare. Let's hope the candidates give them the attention they deserve.
PETER PITTS
The writer is president of the Center for Medicine in the Public Interest, and a former associate commissioner of the Food and Drug Administration.
Some of us hoped that by reforming his party, which has grown so unpopular, McCain could prove that he could reform the country.....
In some sense this whole campaign was a contest to see which party could reach out from its base and occupy that centrist ground. The Democratic Party did that. Senior Democrats like Robert Rubin, Larry Summers and Jason Furman actually created something called The Hamilton Project to lay out a Hamiltonian approach for our day. McCain and Republicans stayed within their lines. There was a lot of talk about earmarks. There was a good health care plan that was never fully explained. And there was Sarah Palin, who represents the old resentments and the narrow appeal of conventional Republicanism.
For those interested, the total number of articles Brooks wrote about the McCain health plan was zero. That's one less than the one he wrote fully explaining Hillary's single payer system...
http://select.nytimes.com/2007/09/18/opinion/18brooks.html
But let's go to the Hamlton project that lays out that Hamiltonian approach Brooks and other pastel Republicans hunger for. Medicare in particular.
Here's what the "centrists" have in mind for the Medicare prescription drug benefit according to
"To encourage price competition and discourage adverse selection, Medicare should allow competition for exclusive contracts to sell the standardized plans in each Part D region. To address the stresses on the federal budget, prices paid for drugs purchased on behalf of beneficiaries previously covered by Medicaid should be reduced to near their former Medicaid levels. To limit the ability of manufacturers to name their prices of therapeutically unique drugs, a standby mechanism for establishing temporary administered prices should be developed."
If you go through the position paper, Frank and Newhouse, two smart people who know better in my opinion, recommend price controls on breakthrough drugs based on the same approach taken by NICE in England. And they would give one drug benefit management firm the right to sell "standardized" plans to by region. That's a backdoor for a national drug formulary and robbing seniors of choice. They argue such a change is needed to encourage price competition, but how will reducing the number of plans increase competition? As for adverse selection, are Frank and Newhouse blind to the emergence of tools to drive patients to the right drug based on clinical and genetic criteria. As Mark McClellan has noted http://www.brookings.edu/papers/2007/04useconomics_frank.aspx
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
