Well, isn’t this wonderful? The Wall Street Journal reports today that “… the G-8 nations [propose] to subsidize the purchase of new vaccines—-for between $800 million and $6 billion—-if pharmaceuticals companies develop ones that meet standards of efficacy and safety. Once the G-8 spends the pledged amount, the drug companies would sell the vaccine at a set discount in the developing world.”

So: Having damaged the vaccine sector seriously with a combination of price controls, regulatory hurdles, and absurd tort liabilities, the bureaucrats and politicians now propose to undo the damage using taxpayer resources, all the while, of course, congratulating themselves for their compassion. Well, how is it that the private sector ever produced vaccines at all? To say the same thing differently, we now are reaping the fruits of decades of destructive policies; now taxpayers will have to assume investment risks that the private sector is in a far better position to evaluate and bear. Moreover, the risk allocation issue is only the beginning; which vaccines will receive favor? The ones that offer the biggest health bang for the buck? Or the ones that are most favored among the politically corrrect? And will “profits,” however defined, be limited while losses are not? Will the various governments attempt to use profits from other investments implicitly to subsidize these favored vaccines? Etc. Just asking.

A recent inspection by the U.S. Food and Drug Administration found some of the drugs Minnesotans order from Canada may not be from the country at all.

Wallace Greenfield discovered one of his “Canadian” drugs came from Greece, and another came from Vanuatu, a small island in the South Pacific.

“I never heard of the place,” Greenfield said.

The U.S. government says it happens all the time and is a growing concern.

“We were beginning to see a pattern of products coming that were purporting to be of Canadian origin coming from various countries from throughout the world,” said Steve Niedelman of the FDA. “We wanted to determine how widespread this was.”

The FDA launched an investigation confiscating thousands of drug shipments headed for the U.S. Some of them were headed for Minnesotans who ordered them over the state’s Web site.

When opened, nearly half claimed to be of Canadian origin, but “85 percent of them were from 27 other countries,” Niedelman said.

“We saw product coming through from Germany, from Australia, from China, from Iran, from Ecuador,” Niedelman said.

The FDA said 30 drugs were counterfeit.

The Minnesota Senior Federation says 25 prescription orders from Minnesota were among those that were confiscated in recent months.

According to Tom Sheck of Minnesota Public Radio (a media never accused of slanting to the right), “When Gov. Pawlenty announced the MinnesotaRXConnect program two years ago, he predicted that it could cover 700,000 Minnesotans and save millions of dollars for consumers. The actual numbers are well short of those projections, and demand for the program has been declining sharply in recent months.”

It’s time for Governor Pawlenty to relenty and stop his unlawful, unsafe and (fortunately) seldomly used state-sponsored program.

Because today it’s just folly, but it could very well turn into state-sponsored health care terrorism.

During my tenure at the FDA I was the senior official in charge of advisory committees. I was proud to oversee a transparent, collegial, and scientific program crucial to the agency’s mission of protecting and advancing the public health.

Today I am upset and worried about the future of this process.

In the wake of FDA bashing for political and personal gain, the advisory committee process is spinning out of control. Witness yesterday’s unexpected chest thumping by members of the Drug Safety and Risk Management advisory committee

The panel voted 8 to 7 to propose a ‘black box’ warning for methylphenidate drugs, sold under the brand names Ritalin, Concerta, Methylin and Metadate, and on the amphetamines Adderall and Adderall XR, stimulants used to treat attention deficit hyperactivity disorder. The warnings could be rescinded if future studies fail to definitely establish any risk.

But the harm to physicians (worried about law suits) and parents (worried about their children), and the children (who aren’t being appropriately treated) would have already happened. What makes this so very frustrating is that the committee didn’t make its recommendation for a black box based on the available data, members of the board said the recommendation was driven as much by worries that the drugs are being overused in the United States as by the possible side effects.

The FDA advisory committee process in the Age of Grassley seems to be “Science? We don’t need no stinking science.”

And even more frightening is Precautionary Principle creep.

According to the Associated Press, “The surprise recommendation has caught the Food and Drug Administration off guard.”

To say the least.

“You don’t want to overscare people with data that aren’t very solid,” said Robert Temple, director of the FDA’s office of medical policy. He said the drugs carry real benefit for some patients. Before the committee’s vote, Thomas Laughren, who heads the FDA’s division of psychiatric drugs, told the committee he didn’t “think we are there yet with this cardiovascular risk” in terms of justifying a black box.

Science? We don’t need no stinking science.

Here’s a headline from a story by Marla Cone in today’s Los Angeles Times …

“Mercury readings high in state.”

Here’s the lead paragraph:

“Californians have among the worst mercury contamination in the nation, with nearly one-third of those volunteering in a nationwide study exceeding the concentration of the potent neurotoxin deemed safe, according to a study organized by two national environmental groups.”

Here’s the 10th paragraph (of an 11 paragraph story):

“The new study, which is ongoing, is the largest test of mercury exposure in the nation. But the results are not statistically representative of the United States because participants were self-selected volunteers. They joined the study by visiting the Greenpeace or Sierra Club Web sites and sending $25 with each hair sample.”

Sloppy, slanted, spurious reporting.
Please pass the tuna.

I’m sure that Senator Charles Grassley and others who think the FDA should view the pharmaceutical industry in a strictly one-dimensional adversarial fashion will be upset to learn that collegial two-way communications is — gasp — good for the public health.

According to a new report, new medicines reach the U.S. market sooner when regulators meet with drug makers before the final phase of human testing and made sure they were addressing potential pitfalls. The report, by consulting firm Booz Allen Hamilton (undertaken at the request of the FDA), said fifty-two percent of manufacturers that consulted the Food and Drug Administration at that time won approval after an initial review, according to an analysis of 77 drug applications submitted from 2002 to 2004. Only 29 percent of companies that did not have such meetings received clearance for their products during the original cycle. (Medicines that fail to win FDA clearance after the original review of typically six to 10 months may go through multiple evaluations before reaching the market.)

A top FDA official said the agency agreed the early meetings with drug makers were productive but said more staff would be needed if the number increased substantially. (This is code for “we need more money!”)

“We have seen a pretty dramatic growth in the number of meetings we’re having with sponsors in the past several years. Any additional workload for meetings is going to have to be supported by additional staffing,” said Dr. John Jenkins, director of the FDA’s Office of New Drugs.

“Early and open communication with the sponsors will allow sponsors to address/resolve issues in a timely manner, potentially within the first review cycle,” the report said.

Once more with feeling everybody, let’s do the budget season chant — “Show me the money!”

Dr. Bob Goldberg pulls no punches in response to Stephanie Saul’s article (“Record Sales of Sleeping Pills Are Causing Worries”) in today’s edition of the New York Times …

Stephanie Saul fits the mold of NY Times reporting on the drug industry like a glove: Big bad companies market lifestyle meds with horrible side effects when simple changes in how we live could easily take care of the problem. Instead of marketing erectile dysfunction drugs, the drug companies are pushing sleeping pills of all things.

Here’s the crux of her article, “… some experts worry that the drugs are being oversubscribed without enough regard to known, if rare, side effects or the implications of long-term use. And they fear doctors may be ignoring other conditions, like depression, that might be the cause of sleeplessness.”

Rare side effects and implications of long-term use? What are the side effects? Sleepiness? That is fairly standard and well known. How do we know they are being over “subscribed?” Saul gives us no benchmark since there is nothing in the article about the extent of sleeping disorders in the United States. Along those line, her claim that experts fear doctors are ignoring related conditions flies in the face of a campaign to make doctors aware that sleep disorders are a component of other illnesses. If she had done a little research, just five minutes of Googling, she could have found that out.

But she doesn’t give us context because Saul wants us to believe sleeplessness was a problem invented by drug companies to sell a useless product. Has she read anything about the increased risk for stroke and sleep apnea? What about the studies reporting up to 80 percent of people on dialysis suffer from insomnia? The fact that most primary care doctors have failed to treat sleeping disorders among people suffering from mental illness, arthritis and fibromyalgia?

A good article would have provided context, history, risks and benefits. As it stands, it is another example of the rotting standards of medical journalism that dwells on the fear factor.

FDA released its Fiscal Year 2007 budget request to Congress totaling $1.95 billion, a 3.8 percent increase over FY 2006.

Nearly $6,000,000 ($5,940,000 to be precise) is new funding for the Critical Path Initiative. This is the first time Critical Path funding has been included in the Administration’s proposed budget.

It’s money well spent and I certainly hope members of Congress embrace this as an important initial investment in the future of American health care.

An initial investment.

In a notice posted on the FDA’s Web site Friday, the agency said it is seeking comments on a proposed study that would examine whether coupons and rebates that are part of some prescription-drug advertisements might cause consumers to think a drug is safer or more effective than it really is. The agency said the study is part of an effort to get “empirical data about consumers’ perceptions” of coupons and how a particular product might be viewed. The agency said information from the study would be used “to justify future regulatory changes.” “Coupons and price promotions may imply superior drug efficacy,” the FDA said.

Well, here’s a cost-saving tip to my buds at DDMAC — coupons do, in fact, attract people to a product. That’s why they’re used. Whether or not an ethical product should coupon is certainly an interesting philosophical question.

But it is in no way a regulatory one.

Here’s Bob Goldberg’s perspective on another aspect of Marc Kaufman’s article …

So typical of the lazy and unsystematic thinking that plagues health care reporting in general. Worrying about generic drug backlog because it’s one of the few ways to reduce “skyrocketing” health care costs” (Actually, health care costs have been slowing in recent years but whose counting. Increased use of medicines is attributed by many scholars — i.e., not journalists — for the slowdown because use of medicines postpones or offsets utilization of surgery, nursing homes, etc.)

Now, how about the delay in the cervical cancer and rotavirus vaccines? The delay in the Alzheimer’s vaccine? The 10-year lag in figuring out that Herceptin should be used in early stage breast cancer because all the trial designs are geared to show maximum benefit from a frequentist statistical standpoint that has no reference to real world use? Taken together these products and uses alone would make the “savings” of the 800 generic medicines waiting at FDA seem a pittance. Has Kaufman ever done a piece on the need or effort to transform the FDA to accelerate the development of real health care solutions. No. You can look it up.

It’s another example of how the MSM fails to get the connection between health care costs and technology: the price of new technologies that are based on a geniune understanding of disease mechanisms and individual responses to treatment are cheap relative to the cost of managing the same illnesses with halfway or no tech approaches. Put another way: what is cheaper, what is more cost-effective: using generic versions of today’s drugs as part of the effort to treat more cases Alzheimer’s, cancer, stroke, diabetes using our current know-how, or treatments that actually prevent or stop these diseases before they develop?

Why do policymakers, pundits and journalists see the efforts and investments of companies pursuing these high tech solutions are evil but see the accelerated development of knock-offs as holy?

In The Washington Post, Marc Kaufman reports that the FDA has a backlog of more than 800 applications to bring new generic products to the market — an all-time high.

FDA, however, has told Congress that the office that reviews new generics needs no additional money, and the agency has no plans to hire more reviewers. “We are very aware that many, many people are waiting for more generics to be approved and that there is frustration about the backlog,” said Gary Buehler, director of the agency’s Office of Generic Drugs.

That generic response is completely unacceptable. The Office of Generic Drugs needs more reviewers and that means it needs more money.

The days of saying “we can do more with less” are over at the FDA. Today, unfortunately, it’s about doing less with less. That is not acceptable.

The generics office’s budget was about $26 million last year. In response to questions from Congress, the agency said the generics program would have to make cuts in 2006 to offset pay raises. Gary Buehler said he expects a record number of applications this year — and an even larger backlog — because “we don’t believe we’ll be getting any staff increases in 2006.” Buehler said his office received an all-time monthly high of 129 applications in December.

And he says he doesn’t need any more money?

“This huge backlog of generic applications is just unacceptable,” said Rep. Henry A. Waxman, one of the sponsors of the law that made generics more easily available two decades ago. “This is the time for the FDA to be ramping up its generic reviews, not to be falling so badly behind.”

I never thought I’d be saying this, but Mr. Waxman is 100% right. But talk is cheap. The question is, what’s he going to do about it?

Henry — show me the money.

Some at the agency and in the industry say the answer is to have generic-drug makers do what brand-name makers did in the early 1990s — pay user fees to finance new hires by the FDA.

Considering the huge profits enjoyed by the generic drug industry, I think this is certainly something to consider.

Plan “B” for “Bob” (Goldberg) …

Fresh from rolling her eyes at the President at the SOTU, Hillary Clinton took direct aim at CMS director Mark McClellan about the what the media has now deemed “the troubled” Medicare prescription drug plan. In full campaign mode, Mrs. Clinton told Dr. McClellan during a hearing “I, for one, believe we should scrap this and start over.”

With what? Hillary didn’t say. But she’s still proud of her record so we can assume that Plan B is Hillarycare Redux. Indeed, after trashing McClellan she took the opportunity to take credit for drug prices going down when she was running the health care show. “We weren’t successful getting the legislation passed, but we were successful sending a message that people better get their prices down,” she said.

Maybe. But back then the market value of biotech stocks also went down. So too did the amount of venture capital flowing into start-ups. Indeed, the amount of money going into biotech declined more sharply when Hillary was threatening price controls than at any other time since biotech has been around. A survey of biotech firms at the time and found that 75 percent of them had 2 years of cash or left in large part because, as the head of the biotech trade group BIO testified at the time “1993 difficult year because in large part investors were scared by the de facto price controls in the Administration’s health care plan. They feared that some widely discussed points of health care reform would mean that they would not recoup their investment in a company that was close to bringing a product to market. According to many press accounts and three BIO surveys of our companies developing therapies for AIDS, cancer, and other deadly and costly diseases, our companies are cutting back on research.”

And the price controls she DID get passed in the Vaccines for Children Program were cited by the Institute of Medicine in 2001 as one reason the vaccine industry is stagnant and unprofitable. Who wants to invest in products knowing your prices are going to be frozen for a decade?

Then there’s Children’s Health Care Insurance Plan she loves to take credit for. This program provides federal money to set up state run low cost insurance programs for working class kids. It was supposed to insure nearly 9 million children. Guess what? Under her stewardship kids were first dumped from Medicaid and then re-enrolled into SCHIP programs. And then it took 4 years to enroll 3 million children. And at the same time, private companies dumped coverage for kids and many parents simply stopped insuring their kids at all.

This page will be more than happy to help Mrs. Clinton promote her health care ideas. Sunshine is the best disinfectant.

Here’s an e-mail that Michael Moore is sending around. (I’ve only included snippets — but you’ll get the idea.) It’s just another high profile example of the Propaganda of Fear, of finding horror stories and packaging them to look like the everyman status quo. The epitome of the one-sided argument. If this project ever sees the light of day, it will have an impact on some of our political leaders — because it’s precisely the kind of drivel they want to hear. It’s the 21st century version of bread and circuses.

That being said, it’s time that we begin our own crusade of good news, of communicating, through truth and hope, the miracles of modern medicine. We must fight the Propaganda of Fear with the Four Horsemen of Conviction, Confidence, Truth and Hope.

Here’s the less from Moore …

Have you ever found yourself getting ready to file for bankruptcy because you can’t pay your kid’s hospital bill, and then you say to yourself, “Boy, I sure would like to be in Michael Moore’s health care movie!”?

Or, after being turned down for the third time by your HMO for an operation they should be paying for, do you ever think to yourself, “Now THIS travesty should be in that ‘Sicko”movie!”?

Or maybe you’ve just been told that your father is going to have to just, well, die because he can” afford the drugs he needs to get better — and it’s then that you say, “Damn, what did I do with Michael Moore’s home number?”!

Send me a short, factual account of what has happened to you — and what IS happening to you right now if you have been unable to get the health care you need. Send it to michael@michaelmoore.com. I will read every single one of them (even if I can’t respond to or help everyone, I will be able to bring to light a few of your stories).

Thank you in advance for sharing them with me and trusting me to try and do something about a very corrupt system that simply has to go.

It’s time that we, the voices of reason and sanity and hope go on the offensive against people like this who, just to turn a buck, will ravage just about anything — including the miracles of modern medicine. Mr. Moore isn’t interested in making things better — but he’s sure interested in making money — the same charges he’s leveling against those in the crosshairs of his camera lens.

Long-term thinking at long last in European health policy? Maybe.

European governments seem to be swapping a bludgeon for a scalpel when it comes to cutting the cost of medicines. According to Reuters, drug makers should not expect an end to the overall drive to squeeze prices but there are signs of a more discriminating approach that may actually help “big pharma”, according to industry executives and analysts. Andrew Witty, head of European pharmaceuticals at GlaxoSmithKline Plc said a growing number of governments are now realizing that healthcare reforms must include rewards for innovation.

“There are still a few governments that are very focused on short-term, non-discriminatory cost measures, where they simply cut prices and they donç©° really care if it is an innovative product or an old one, but they are getting fewer,” he told Reuters. ‘There are more and more countries where we are seeing governments get much tougher on the prices of old, off-patent medicines and being prepared to reward meaningful innovation more quickly and more fully.” For companies like Glaxo, which relies heavily on sales of newer drugs, that is good news.

European pharmaceuticals growth is hovering around a 10-year low with sales in the top five markets — Germany, France, Britain, Italy and Spain — rising just 3% in the 12 months to November, according to IMS Health. Yet Merrill Lynch believes the worst effects of European pricing reforms may now be over, with Germany in particular showing signs of recovery. Growth in German pharmaceuticals has picked up to 7%, from 1% in 2004, largely as a result of a cut in mandatory manufacturer rebates to the government, the investment bank said in a report this month.

Here’s an unsolicited e-mail that I got today …

Dear Peter Pitts:

It’s a well-known fact that Consumer Reports provides expert advice
and unbiased information and Ratings. Each year, we report on
thousands of products — everything from cars to computers, tires
to treadmills.

But did you know … we also offer independent, trustworthy medical
advice and top treatment Ratings for over 100 common conditions,
including back pain, obesity, ADD, and breast cancer, among
many others?

INTRODUCING … Consumer Reports MedicalGuide.org.

This new, interactive Web site will empower you to take charge of
your healthcare. The assessments and ratings it provides are based on
the best evidence from clinical reports from around the world, in
partnership with the British Medical Journal. And because we don’t
accept advertising, not from drug companies or from insurers, we are
free to say what works, and more importantly, what doesn’t.

So, whether you’re researching an existing medical condition or
wondering what drugs adversely interact with your new prescription,
Consumer Reports MedicalGuide.org has the answers.

I will not be subscribing to this marvelous opportunity. You can draw your own conclusions.

Paul Krugman wrote an op-ed singing the praises of what he calls the socialistic health care system of the Department of Veterans Affairs. He was taking a page from a speech given by Hillary Clinton the week previous to his editorial in which she outlines a new vision of Clintoncare where government still runs the show but uses electronic patient records, price controls and government drug lists to make medicine more efficient. The following lengthy deconstruction by Bob Goldberg is must reading for anyone who wants to fully understand the manner in which Mrs. Clinton and others shround their effort to nationalize health care with deliberately misconstrued interpetations of obscure research publications they know journalists are too hurried to track down and seemingly erudite (but misinformed) discussions of the impact that market forces and medical technology have on the American health care system.

Here’s the link:

Download file

Here is a link to an important perspective on the FDA’s new physician labeling rule. It’s penned by AEI scholar and CMPI advisory board member Jack Calfee.

Download file

Big news that will surely generate big controvery …

The New York Times and other media report that the European Union’s drug regulator recommended approval on Friday of a generic version of a growth hormone, a step forward in attempts to get approval for copies of biotech drugs.

Regulators in the European Union and the United States have not yet approved any so-called biosimilar medicines amid fears over safety and pressure from makers of patented biotech drugs. One big concern is that biotech drugs, unlike traditional chemical compounds, are too complex to copy easily and safely.

The European Medicines Agency said that studies on Omnitrope, a growth hormone made by Sandoz, the generic arm of Novartis, showed comparable quality, safety and efficacy to Genotropin, a Pfizer drug already approved in Europe. The decision should pave the way for the European Commission, the European Union’s executive arm, to give formal approval to Omnitrope within a few months.

Europe issued guidelines for biosimilar medicines in 2004, laying out the steps needed for regulatory approval. That has made it easier to file than in 2003, when the European Commission declined to approve Omnitrope, said Andreas Rummelt, chief executive of Sandoz.

Oops. I made a mistake in yesterday’s blog entry (“Lack of Evidence-Based Accusations”). I referred to Dr. David J. Rothman as President of the Institute of Medicine. He is, in fact, President of the Institute on Medicine as a Profession. I have to admit that my initial reference came directly from the New York Times article on the JAMA editorial. (And I should know better than to take whatever appears in the New York Times as entirely fact-checked.) Mea culpa. (It’s like they say, everything you read in the paper is true, except for those things you know about personally.) What I find most interesting about this correction is that Dr. David Rothman isn’t even an MD — but he sure has strong opinions about who should be visiting their offices.

I also want to clarify my statement about the JAMA article’s lack of evidence. There certainly are plenty of citations — but not a jot about patient outcomes. How trivial! Further, the authors of the article view the visits of pharmaceutical sales reps as the only variable on a physician’s prescribing behavior. What about formulary restrictions? Or payment incentives? Or counter-detailing efforts, tiered co-pays or payor-switching? Details. Details. Details.

The concept that big, bad Pharma is to blame for everything isn’t just simplistic and sophistic but deleterious to a serious conversation about the issue. Rather than trying to point a finger, the authors should pick up a mirror.

This week’s recommendation in the Journal of the American Medical Association (that all but eliminates any role for pharmaceutical or medical device companies in teaching doctors about their products) reveals a lot about the medical profession’s anxiety about the integrity of some of its members.

First, as Peter Pitts notes below, there is no published evidence that relationships between manufacturers and physicians harm patient care. I am not a physician, but I can read Dr. Wazana’s article as well as anyone else. In her literature review of pharmaceutical sales practices, previously published in the same journal, and relied upon by the authors of this week’s proposal, she concludes that “no study used patient outcome measures”. The “negative outcomes” that she measured included physicians developing a “positive attitude toward pharmaceutical representatives” as a result of an interaction. That’s hardly a scandalous endpoint!

The term “health industry” is also interesting: the authors include drug and medical device makers in this “industry”, but not physicians, even though they earn their livings in it too! There is also an assumption that “education” and “influence” are mutually exclusive, but this is absurd: one cannot educate without influencing. Undoubtedly, drug and device makers seek to influence physicians, but that does not mean that the influence is uneducational.

Of course, the biggest unasked question is: where will the money come from to conduct education, if the corporations are banned? One answer could be that the physicians, as a profession that enjoys a government-granted monopoly on prescribing, should levy the costs of education on themselves. However, I am not aware of any study estimating what the per capita levy to cover these costs would be. I also doubt that many physicians will be enthusiastic about this proposal, once they face the full costs of their continuing education.

Nor is it out of line to accept that manufacturers’ reps are the best source of information for that medicine or device. Because I seem to be fond of automobile analogies lately, let’s try another one. A friend of mine owns a Volvo. Volvo pays for the head mechanic to go back to Sweden for training at the Volvo factory every year or two. This gives her the confidence that the dealership will service her car optimally. Imagine a Volvo dealer who proclaimed that he never let Volvo reps on his lot, or allowed them to train his staff, and forbad all communications with the manufacturer. That would not give you confidence that this was the man from whom to buy a Volvo, would it?

I realize that this is not a perfect analogy, but it illustrates the importance of understanding that the socially optimal level of drug makers’ “influence” over physicians is certainly greater than zero.

Refs.:

Brennan, T.A., et al. 2006. “Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers”. Journal of the American Medical Association 295(4):429-433.

Wazana, A. 2000. “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” Journal of the American Medical Association 283(3):373-380.

A few key paragraphs from an editorial in today’s Wall Street Journal on the new Physician-Labeling rule:

So you might think everyone would welcome the Food and Drug Administration’s latest initiative to tackle the problem by requiring simplified labels with the most important information prominently displayed. But not some Democrats on Capitol Hill, who are so dependent on their trial-lawyer donors that they are fighting to preserve the current climate of uncertainty and confusion.

“A typical abuse by the Bush Administration,” said Ted Kennedy after the announcement last week of the FDA’s new labeling rule. House Democrat Maurice Hinchey said the FDA had “gone to bat for the drug industry.” He is threatening legislative action. And of course the lawyer (er, “consumer”) advocates at Ralph Nader’s Public Citizen piled on.

If drug makers are going to be asked to simplify labels, it only makes sense for the FDA to reassure them that the sound science embodied in its labeling oversight will still be held to “pre-empt” contrary findings at lower levels of government.

The FDA’s reassertion of the pre-emption doctrine is really nothing new, as some recent cases demonstrate … In Dowhal v. SmithKline Beecham, a plaintiff argued that nicotine replacement products be required to warn that they might theoretically cause birth defects. But the FDA had already considered and denied requests for such a warning because it believed the known risks of a mother’s continued smoking to a fetus far outweigh the known risks of nicotine itself. Again, there was the possibility of the court issuing a ruling in direct contradiction of federal law, and again the FDA intervened.

It’s hard to think of a case that better illustrates the moral bankruptcy of the Kennedy-Hinchey-trial lawyer position here than Dowhal. The kind of labeling and litigation environment they are fighting to preserve would probably have the effect, among others, of more women continuing to smoke during pregnancy. Overwarning on medications can be as much of a risk to public health as underwarning.

Our only concern is that this latest assertion of the pre-emption doctrine may not be enough to rein in state courts that have ignored it before. Congress might also consider making the FDA’s supremacy in drug safety matters clearer in statute, lest the Vioxx cases and others do irreversible damage to a vital American industry. Or, if Congress doesn’t like pre-emption, it could always dissolve the FDA and leave the matter entirely to the tort system. What should be unacceptable is to leave companies, as now, subject to the double jeopardy of FDA approval followed by tort-law second guessing.

Well said!