Latest Drugwonks' Blog

On 2/4, blogging on a report that there was a backlog of generic drug applications at the FDA, I suggested that the agency seriously consider user-fees for this important area of responsibility. And it looks like that’s going to happen.

Scott Gottlieb, the FDA’s feisty and forward-looking deputy commissioner for medical and scientific affairs plans to tell the generic drug industry today that it is time for the government to charge its member companies fees so the agency can hire more staff and exprdite the processing of applications to market new generic medications.

In a speech he is scheduled to deliver to the Generic Pharmaceuticals Association in Florida, Gottlieb plans to say that user fees — like those paid by the makers of brand-name drugs, medical devices and animal drugs — are needed to keep up with generic reviews.

“From our perspective at FDA, we have seen user fee programs applied to our medical device and new drug programs with great success,” a copy of his speech says.

Gottlieb is scheduled to say in his speech that raising funds from generic-drug companies would allow the agency to review applications faster, to have more scientific data analyzing whether proposed new generics are equivalent to established brand-name drugs, and to address potential safety issues once the drugs are on the market.

Per Scott, “It’s not fair to compare our work in our generic drug office to our work in the new drug office, as some have done, without acknowledging that our new drugs program has benefited from funding tools that are not available to us when it comes to generic drugs.”

Use of generic drugs — which must be equivalent to the branded products that they duplicate — has been growing steadily, with more than 53 percent of prescriptions now filled with generics. That percentage could increase
quickly because an unprecedented number of major branded drugs will lose their patent protection in the next few years.

In addition to raising the user-fee issue, Gottlieb is set to outline a number of agency initiatives to speed generic reviews. One is a formal lifting of a ban on direct telephone conversations between FDA reviewers and generic drug makers. Another involves grouping bioequivalence review applications for the same or similar drugs.

You tell em Scott.

Talk about being a Nabob of Negativism! Families USA (the political lobbying group that masquerades as a “citizens advocate”) is downright gleeful in it’s grossly premature burial of Medicare Part D. According to its new report (a love note to the Intelligensia of Interference issued on Valentine’s Day) the Bush Administration has “significantly lowered” its enrollment projections for the new drug benefit.

Really? I don’t recall anyone from the White House saying that? Maybe Ron Pollack, the Families USA “Godfather,” meant White Castle? And I certainly didn’t hear Mark McClellan say anything remotely like that during his recent, highly publicized congressional testimony. And I didn’t read it in a Robert Pear column. So could it really be true?

No. I think that the Godfather must be hearing voices — and that those voices are “interfering” with his cognitive processes.

Giving a new and draconian meaning to “family-friendly,” Godfather Ron also concludes that a vast majority of those enrolled in Part D already had drug coverage before the benefit began and that only “a very small fraction” of beneficiaries eligible for the low-income subsidy have entered the program.

Methinks that the Godfather would like the truth to sleep with the fishes. This new report is just another example of reality non-interference.

I suppose that Families USA expected 100% sign-ups with zero problems after almost a month and a half! Can’t this administration do anything right!

Proving that they are most decidedly living in a Pelosi-induced fantasyland, Godfather Ron commented, “It’s truly disappointing to see such a large number of seniors not get the benefits to which they are entitled.” He further added that the drug benefit has so far “produced rather meager results.”

I guess he thinks that if he keeps saying that enough times people may actually start believing him.

CMS spokesman Gary Karr politely suggested that Families USA spend its time and energies more productively by helping to expand the number of seniors enrolled in Part D instead of taking “ill-informed partisan potshots.”

Good for you Gary.

Karr then said that CMS has not downgraded their enrollment estimates. “The numbers that [Families USA] cite come directly from us. We’ve been open and above board about exactly what those numbers are and where we get our estimate of the 28-to-30 million.” Families USA, citing a January 28, 2005 CMS Federal Register notice, said that the administration had been projecting that 39 million beneficiarieswould enroll.

But it’s the Godfather of Garbage and his “Family” who are doing the projecting. For them it’s all about political spin and vituperative spittle. Anything for the cause.

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.


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.

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