The FDA has decided to shelve its plans of opening an Indian office to help expedite regulatory clearances for Indian drug exporters to US.

Sources said Dr David Lepay, the FDA’s Senior Advisor for Clinical Science and Director, GCP Programs revealed at a session on Asian clinical trials at the 42nd annual meeting of the Drug Information Association (DIA) in Philadelphia, USA, that the US food and drug regulator was not planning to set up offices neither in India or anywhere else in Asia, at present. The announcement from the FDA official came in the presence of Dr Ashwini Kumar, Drug Controller General of India (DCGI), who was also a speaker at the program.

Pharmabiz had reported about two years ago that the FDA was planning to start its Indian office at New Delhi with an initial investment of about $5 million, considering the fact that India has the maximum number of FDA-approved facilities outside the US. This office was to facilitate Indian companies with the procedures of filing for marketing approval for products to be launched in US, application for site inspection and other procedures dealing with the FDA. The office was envisaged to facilitate the exchange of communication between Indian companies and the US authorities, thereby saving a lot of time and resources, sources had told Pharmabiz.

Dr Leepay told the seminar, attended by a good contingent of Indian participants, that it was not mandatory that a new drug marketing application in the US be supported by a US study and there had been instances of marketing applications wholly supported by non-US studies. However, the FDA had criteria that non-US studies were expected to meet US standards and that non-US data was reviewed to the same standards as data from the US. Though the FDA had a long history of inspection of clinical trials outside the US, its experience in the Asia/Pacific region was limited, and the region currently accounts for only 5 per cent of FDA’s international inspections. He also clarified that the FDA does not certify clinical investigators, clinical sites, sponsors or ethics committees, nor does it approve study protocols or informed consent documents.

Here’s one of CMPI’s Scientific Adviser Peter Hotez, (and recipient of a Gates grant for his work on the development of a vaccine against hookworm) on how the Bill and Melinda Gates Foundation does it’s good work…

http://abcnews.go.com/Video/playerIndex?id=2121626

The latest broadside against the FDA is by Congressman Waxman who argues the FDA is doing a lousy job by not prosecuting and attacking companies who are producing inferior products, engaging in mislabeling or selling suspicious goods. This is the sort of after fact enforcement activity that pols love since it gives them something to hold hearing about. I call it regulation by body count since it requires people to die or be harmed in order for a regulatory or enforcement act to take place. In contrast, since Mark McClellan became commissioner in 2003, the FDA has sought to improve overall product quality through manufacturing efficiencies, risk management programs and other quality improvement efforts that are not politically sexy and often take years and millions of dollars to implement. (Not to mention cooperation. ) Indeed manufacturing is part of the Critical Path lest anyone forgets.

Of course, the drive by media ignores all of this. And the FDA has not done enough to get the message out about these important initiatives. One more thing: Why does Gardiner Harris refer to the ‘conservative’ American Enterprise Institute and the ‘watchdog’ Public Citizen? Public Citizen is nothing but ‘liberal’ and as for watchdog, that is a matter of opinion, not absolute truth. Even a Rockefeller can figure that one out.

Report: Many Americans Too Willing To Ask For Help
June 26, 2006 | The Onion, Issue 42*26

BETHESDA, MD — A National Institutes of Health study released Monday revealed that Americans are excessively, almost pathologically eager to seek help for various personal, psychological, financial, organizational, and sartorial problems. “American citizens are four times more likely to seek counseling than Canadian citizens, eight times more likely than the British, and 900 times more likely than Germans,” said the NIH’s Dr. Anne Hanratty, who authored the study. “In addition, they seek help an average of seven times faster than citizens of other nations, sometimes only a few hours after they undergo any emotion or experience that could be interpreted as negative or problematic.” A related study showed that Americans are nine times less likely to seek help for medical matters, such as high cholesterol or colon cancer screenings, but 85 times more likely to ask for second helpings.

At a time when the social scientists are telling us that post 9/11 Americans are more safety-conscious/risk-averse then ever before — while at the same time looking to medical science for ways to live longer, healthier lives at lower costs — the announcement that the FDA is going to lead the charge towards a 21st century model for clinical trials is good news — very good news.

Here’s the announcement. Further detail can be found at www.fda.gov.

FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring

The Food and Drug Administration today announced a series of new policy and regulatory developments to strengthen the Agency’s oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency’s approach to bioresearch monitoring as part of the Critical Path Initiative. The Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) Initiative will facilitate the modernization of the regulation of clinical trials and bioresearch monitoring, specifically the protection of human subjects and the integrity of data in clinical trials, and encompasses devices, foods, human drugs, biological drug products and veterinary medicine.

The new effort is part of an HHS-wide initiative to employ recent advances in basic science, including genomics and molecular analysis, in order to bring about more effective development and review of therapies, and to enable increasingly targeted and individualized care management for patients.

“As clinical trials continue to evolve, in particular becoming increasingly large, decentralized and global, the FDA’s approach to bioresearch monitoring and human subject protection must also evolve and modernize,” said Janet Woodcock, FDA Deputy Commissioner for Operations at this year’s Drug Information Association annual meeting. “BIMO will help FDA modernize biomedical research monitoring making the most efficient use of its resources to help ensure the safe conduct of clinical trials, including taking appropriate opportunities to leverage existing oversight done by private entities to accomplish the Agency’s risk minimization goals.”

Clinical trials have evolved dramatically since FDA first began inspecting them in 1977. In an effort to protect the rights and welfare of human subjects and to verify the quality and integrity of data submitted for review, FDA established over time a bioresearch monitoring program that included the development and implementation of compliance programs to provide guidance for inspections of investigators, sponsors, contract research organizations, institutional review boards and bioequivalence facilities. With the expansion of clinical trial studies and sites, electronic record-keeping in the studies, and greater participation by vulnerable subjects in clinical trials, the role of FDA’s bioresearch monitoring compliance programs must expand and evolve as well. The HSP/BIMO Initiative addresses that need.

Over the past year and a half, FDA has carefully inventoried its programs and identified issues to launch the HSP/BIMO Initiative. As this initiative moves forward, FDA will continue to gather additional issues for the initiative and related information from internal and external stakeholders, e.g., industry, academic, and government activities and programs, and intends to conduct workshops and create other opportunities for public input.

Janet Woodcock, M.D., Deputy Commissioner for Operations, will chair the HSP/BIMO steering committee which is comprised of representatives from the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Food, Safety, and Nutrition (CFSAN), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), and the Office of the Commissioner (OC).

Caution needed in helping the FDA
By Boston Herald editorial staff
Sunday, June 25, 2006

The top Republican and Democratic members of the Senate committee dealing with health, Sens. Michael Enzi of Wyoming and our own Ted Kennedy, have begun preparing a bill that would give the Food and Drug Administration new powers over drug safety.

Some new powers are needed, but we fear Congress may go too far.

Senators are reacting to the withdrawal of Vioxx and similar drugs after the discovery that these stomach-friendly painkillers increased the risk of heart attack when taken for 18 months.

The FDA would get the ability to order changes in a drug label after it goes on sale and the power to force manufacturers to live up to any promises to conduct post-approval safety studies. Experience shows these are needed improvements.

But the bill reportedly (a text is not yet available) sets up dispute resolution procedures and requires the FDA to publish formal plans for evaluating and mitigating risks of every new drug, complete with schedules and timetables. All this would just augment the agency’s “avoid mistakes” culture. Its bureaucrats know they will be pilloried for approving a drug that later reveals problems, but will be left alone if overcaution delays the sale of something useful.

Caution has costs. Approval of Erbitux, a new treatment for colon cancer, was withheld in 2001 because not all the study patients had failed conventional therapy. The drug was approved 27 months later. Colon cancer strikes about 8,700 people every month; Erbitux (used with another drug) halts tumor growth for 4.1 months. The delay thus cost about 80,000 person-years of tumor arrest.

The FDA has improved its once-draggy performance. Average time to approval of new drugs fell from 22 months to 14 from 1993 to 2003; time to approval for promising drugs in fast-track review fell from 13 months to six. Congress should do nothing to slow it down.

Frank Lichtenberg of the Columbia Business School has estimated that on the average each new drug approved in 1970-1991 saved 11,200 person-years of life in 1991 alone, and presumably each year thereafter. New drugs yielded a return to society of 40 percent per year on the cost of development, he calculated.

All drugs have side effects. The senators would do well to encourage the taking of worthwhile risks, perhaps by mandating the use of sound cost-benefit analysis in surveillance of drug safety.

Great piece today in the NY Post by Dr. Marc Siegel about how the fearmongering by the media and certain members of Congress is driving his patients away from taking medicines that can keep them alive. Marc has written well about how we should use science — not fear — to guide policy and medical decisions.

Here’s the entire article:

POLARIZED PILLS
By MARC K. SIEGEL

June 23, 2006 — MEDICINES are too often portrayed as either life savers or killers - a polarization of our pills that serves neither science nor health care.

Thanks to two high-profile lawsuits, my patients are now asking me if Lipitor - the cholesterol-lowering drug - is still safe. With the suits claiming that Lipitor can cause brain and nerve damage, my old comeback - “I take the drug myself” - is no longer sufficient to calm fears. One patient tells me that I’m blindly ignoring the risks of serious side effects.

In fact, Lipitor, the country’s top-selling prescription drug, has been shown to prevent the progression of coronary plaques in patients with heart disease, and is likely to be as useful in patients who are at risk for heart attack and stroke from these same plaques.

The most potent drug in the class known as statins, Lipitor has been successfully administered to millions. In very rare cases, it can trigger a severe muscle breakdown known as rhabdomyalysis. It has never been proven to cause memory loss or nerve damage, and I and most other physicians believe it to be a safe and effective drug.

So why the worry? Part of the problem is the way the drug industry hypes its products, setting them up as some kind of panacea. But if it’s sold as a magic elixir, the discovery of any flaw rings alarm bells.

Not all drugs that are victims of the pendulum swing from panacea to panic are as famous or as successful as Lipitor. This month, an FDA safety panel also cancelled a study where 4,000 children were to receive the antibiotic Ketek, an effective treatment for bronchitis and sinus infections. Why stop the study? Ketek, a new drug, has been prescribed to over 5 million people over the past two years, but 12 have sustained liver failure (in four cases, fatally), while 23 others have suffered damaged livers.

Should Ketek be restricted, labeled with ominous warnings or taken off the market entirely? Not without much better evidence of danger. At a time when few new antibiotics are being developed, drug-resistant bacteria continue to emerge, drugs like Ketek are important tools.

Unfortunately, when the media and the lawyers target a drug, they overlook the fact that the side effects are rare, and/or alternative treatments more problematic. Sober statistics-based analysis gets tossed aside. The drug-maker’s stock price and the number of prescriptions written plummet.

Decisions on drug safety should be based on real facts - a weighing of the real risks and benefits. Hysteria doesn’t belong in the drug-safety equation.

Dr. Marc K. Siegel is an internist at NYU Medical Center and associate professor at the NYU School of Medicine.

Owing to genuine concerns about pedigree and counterfeiting (courtesy of the FDA’s aggressive use of the Bully Pulpit), together with the successful rollout of the Part D drug benefit, the issue of foreign drug “re-importation” has lost much of its political allure and momentum. Most of the elected officials calling for the “legalization” of foreign drugs have since abandoned their incautious and dotty schemes. Aeternum vale!

But political bloviation abhors a vacuum. Taking the place of drugs are too expensive is the new clarion call of drugs are not safe. A sure-fire political winner. After all, who could be against “safety?” Safe = Good. Unsafe = Bad, right? Well, not exactly. As Dr. Mark Goldberger, director of FDA’s office of antimicrobial products commented, “It’s more complex than it seems at first glance.”

Safety has been hijacked. Safety is the new Re-Importation. But it’s the same old story.

And it sure plays in Peoria or, perhaps more appropriately, in Des Moines. Not surprisingly, the media loves it because; although the pressure point is different the “victim” (the patient) and “the villain” (the pharmaceutical industry) are the same. And, as everyone knows, it’s more than okay to kick the stuffing out of Big Pharma (or, if you prefer, “Big Pinata”). It’s a free hit. Sanctimonious quotes and macho strutting results in terrific headlines for the folks back home.

A little harmless politicking? Hardly. Just ask the people who no longer have access to the medicines they need (like Vioxx), or to those who will suffer needlessly in the wake of Tropical Storm Safety — since the inevitable result is a dearth of new medicines in the pipeline.

Is it safe? Ask the FDA. Is it politically safe? Ask a Senator. Is it remunerative? Ask an attorney.

What does “safe” mean, anyway? 100% safe? Certainly not. All drugs have risks as well as benefits. And more often than not the more serious the disease the more serious the risks associated with the treatment. Consider advanced non-small cell lung cancer. Then consider Iressa. Are such medicines risky? Indeed they are. Are the diseases they treat serious enough for patients to accept such risks? Decidedly. Consider Multiple Sclerosis. Then consider Tysabri.

But most importantly, consider the Precautionary Principle, the one-dimensional dogma that dictates that nothing should be done until everything is understood. Prudent? No, puerile. And the unintended consequences are fatal. Fatal like in no new medicines. Fatal like in death.

Is it time to recall Ivory Soap? Is it safe? After all, it’s only 99 44/100% pure.

I should also add that the VA doesn’t pay pharmacy costs. And that’s anywhere between 20%-40% of the purchase price. One more time folks — a half truth is a whole lie.

Here’s an email I received from a producer at ABC about the Families USA “study.” The fact that it gets plastered and picked up as the default position that has to be defended against should tell you all you have to know about coverage bias…but read the entire email and get a load of the stacked questions I am supposed to answer. The full article about FUSA was attached to the email.

” Pasted below is Families USA News release on the cost of drugs under the Medicare prescription drug plan. World News Tonight Weekend is interested in a possible story looking at the issue of whether prescription are in fact now costing LESS for MORE seniors. Below are some questions. We will forward your responses to the ABC News correspondent and producer working on this story.

-What are your views on whether most seniors are or are not saving money on prescription drugs?If they are saving, could they be saving more? And if so, why not?

-Are prices of many of the most popular drugs going up? And if so, why?

-And what is the longterm impact on the plan of those rising prices?

-Are seniors who are saving on some drugs, just losing those savings to other now more expensive ones?

-And are the drug companies making even more money now because of this plan? “

Oy gevalt!

The battle continues apace. Please have a look at this new op-ed (penned by myself and Dr. Bob) that appears in today’s edition of The Washington Times.

And please pass it along.

Here’s the link:

http://www.washingtontimes.com/op-ed/20060621-085649-7788r.htm

I am being cautioned not to regard the two page summary upon which most of the news accounts of the Enzi-Kennedy bill are based as definitive or the final version. Indeed, the two page summary ignores the creation of an agency that would support the creation of tools that would accelerate drug development and promote targeted medicines. The agency would use public and private partnerships such as the Critical Path Institute to fufill the mission and objectives of the Critical Path initiative. This is an imaginative and thoughtful effort to modernize the FDA through scientific collaboration.

In context then, the onerous risk management proposals set forth in the two page summary seem to be totally inconsistent with the effort to improve drug safety post market by increasing the pre-marker ability of the FDA and companies to identify and select populations that would respond significantly to medicines and provide biomarker based screens to reduce the rare liver and heart problems associated with drugs.

Instead, the risk management program is mainly busy work and studies of the sort that will never identify rare events with the certainty hope for by proponents. In particular the risk management effort post market makes the nightmare Scott Gottlieb fears — of physicians too worry of prosecution or lawsuits or too busy to comply with yet another mound of risk management paperwork, tests, followups — controlling clinical decisionmaking of doctors. It is also an example of the agency — not the doctor or patient — deciding what is best for them.

How shameless can a politician be…Chuck Schumer attacking Merck for lowering it’s Zocor prices in response to impeding generic competition..Interestingly, when he introduced changes to the law promoting generic drugs he lauded his proposals as “all about promoting competition in the drug industry…” Except when it comes to creating competition for generic drug firms? Since when did they become a protected class and since when did protecting them become more important than consumers. Since about 15 percent of consumers stick with a generic after a switch, a Zocor price slash will save them money, Schumer rather than later.

June 20, 2006, 2:03PM
Senator Raps Drug Giant Over Zocor Price

By DEVLIN BARRETT Associated Press Writer
© 2006 The Associated Press

WASHINGTON â A New York senator accused the drug giant Merck & Co. on Tuesday of conspiring to undercut a cheaper generic alternative to its cholesterol-lowering drug Zocor just days before it becomes available to patients.

Sen. Charles Schumer, a Democrat, charged that Merck is quietly collaborating with health insurance companies to create lower copays for customers buying Zocor than for those buying the generic equivalent.

Zocor generated $4.4 billion in sales last year, and generic alternatives will be available for the first time on Friday. A company executive scoffed at Schumer’s allegations.

“It appears that Senator Schumer is criticizing us because he says that our prices are too low. That’s a new one,” said Ian Spatz, Merck’s vice president for public policy.

“The truth is that we support generic competition and the generic competition for Zocor is good for patients. It’s good for people who have to pay for medicine, which include health plans. We’re going to continue to price it competitively,” he said.

Both Peter and I were concerned about Gardiner Harris’ article in the NYT which depicted the Enzi-Kennedy FDA bill as a throwback to go slow paper gathering approaches to drug safety without regard to 21st century science orproposals to accelerate a response to the more expensive and prevalent ‘side effects’ of having a disease like Alzheimer’s without effective treatments.

As the Yiddish proverb goes: “A half truth is a whole lie.” The bill does encourage risk management activities and trial disclosures. But Senator Enzi and Kennedy have spent a whole lot of time on Critical Path issues and discussing the science behind it, how to fund it, etc. There is a considerable amount of attention and language devoted to accelerating drug development and using biomarkers and other methods to encourage targeted — and safer — medicines.

Why did Gardiner leave this out? Were his sources selective or was he?

One possible clue: Here’s a guy who has a problem differentiating between suicide and suicidal ideation, ignoring research that demonstrates that suicide has gone down with use of SSRIs and the role that genetic mutations play in causing adverse reactions to SSRIs and other antidepressants one of which is suicidal thinking (which is NOT suicide).

But, to be fair, he is not alone in this, so we’ll give Gardiner the benefit of the doubt.

The take away from all this: those opposed to the Critical Path and faster cures will use the MSM to shape public perception. The reality is more robust and hopeful. And as Anna Mathews mentions in the last line of her story in today’s Wall Street Journal, the bill “would authorize some resources for an FDA effort to spearhead research on drug evaluation.”

Can you say penny-wise and pound foolish? This from Health IT News.. The GOP stalls a bill to encourage the diffusion of health IT because it might — I repeat might — drive up health care spending in the short term as people invest in new hardware and systems to achieve interoperability and patient-centered. Would these Republicans have stalled investment in the highway system or the transcontinental railroad because it drove up costs in the short term?

http://www.healthcareitnews.com/story.cms?id=5109

House Republicans stall healthcare IT bill
Healthcare IT News
By Bernie Monegain, Managing Editor 06/20/06

WASHINGTON â A healthcare IT bill the U.S. House of Representives was expected to vote on this week is expected be put on hold.

Congress Daily reports the move to hold off on the bill came after the Congressional Budget Office forecast the legislation would increase spending and reduce revenue.

The bill bill promotes the adoption of healthcare information technology and calls for national standards for implementing electronic health records.

EU, US To Cooperate Against Counterfeit Goods

BRUSSELS (AP) —The European Union and U.S. plan to tackle together the traffic of fake luxury items, pirated music and counterfeit medicines with a deal set to be signed Tuesday that aims to help improve intellectual property rights protection in countries such as China and Russia.

The 25-nation bloc plans to work with the U.S. to train customs officials, exchange information and send anti-piracy experts to countries where counterfeiting is rife. The E.U. warns that countries that tolerate black market counterfeit goods could lose out on foreign investment and trade.

E.U. Trade Commissioner Peter Mandelson and E.U. industry chief Guenter Verheugen plan to sign the anti-piracy strategy Tuesday and U.S. President George W. Bush and European leaders are to give it their backing Wednesday at an E.U.-U.S. summit in Vienna, Austria.

Initial efforts will focus on working with China and Russia, the E.U. said, but the plan also includes other countries in Asia, Latin America and the Middle East.

Trade in fake medicines is also flourishing, estimated to make up almost 10% of the world trade in medicines in 2004, according to the E.U. executive.

The Journal of the American Medical Association — JAMA — is an island unto itself that seeks to generate revenue and readership by taking politically correct and activist positions that the hit and run media will print. Such an approach comes at the expense of the public health. And the FDA’s commissioner for Medical Affairs Dr. Scott Gottlieb said so in dulcet and diplomatic tones to the AMA: In his speech Gottlieb said JAMA spends too much time and spending too much time politicking and not enough time teaching how to appropriately prescribe the new medicines coming to market. The failure to prescribe drugs according to how they are developed and approved is the single largest source of serious side effects drug that fearmongers like Grassley love to talk about. The simple solution is better communication, between companies and the FDA, and doctors and patients…a low tech solution in a high tech age… And there is another solution too — drugs can be tested to determine how well a person metabolizes them before they are prescribed. That includes drugs like warfarin, antidepressants, ibuprofen and beta blockers…That could avoid costly and serious problems. Where is the JAMA editorial calling on the profession for DNA typing in primary care?

Here’s an interesting and provocative story. Please note that one point I made to this reporter (not entirely represented in the final piece) was that RMPs play a very important role — but that they must be joined by other more innovative and inclusive programs.

Gottlieb Speech Signals a Sea Change in FDA Drug Safety Strategy, Advocate Says

Stephen Langel
Drug Industry Daily, June 19, 2006

A senior FDA official’s speech urging the agency to pull back from requiring risk management plans as a part of the drug approval process signals a major change in the FDA’s thinking on drug safety, an industry observer says.

Scott Gottlieb, the agency’s deputy commissioner for medical and scientific affairs, announced in a June 12 speech before the American Medical Association that risk management plans (RMPs), while important in some instances, may be too prevalent. As the requirement for RMPs becomes more pervasive, the burdens could become too much for physicians and their patients, he added. “I worry about the future,” Gottlieb said.

Instead, the agency should look to a more collaborative approach, placing more responsibility on the medical community’s shoulders to ensure that medicines are used correctly, Gottlieb said.

“I believe some of the same safety goals embodied in the RMPs could be achieved if we had more ability to collaborate more closely and effectively with physician organizations,” he added.

This announcement shows that the agency has realized that there is a better way to enhance drug safety than requiring RMPs, Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, told DID. This speech is a “very clear signal to people within the agency” that a change is necessary, he added. Drug safety “cannot be viewed as a punitive measure.”

Up to now the agency has used RMPs to show that they are doing something about drug safety, but these plans are an empty measure of success, he said. Gottlieb’s speech shows the agency is ready to stop “hiding behind” RMPs and take a better approach, Pitts added. Because doctors have the final say over their patients’ use of drugs, they must be more involved in the drug safety process. It is “crucial” for the collaboration that Gottlieb spoke about to take place, he said.

This speech may have been timed to coincide with ongoing Prescription Drug User Fee Act (PDUFA) negotiations and a growing call in Congress for a new FDA office to handle drug safety, Pitts said.

PDUFA is a vehicle for the agency to receive much of its funding, but that funding is tied to the FDA meeting specific performance goals. The speech may be a signal to Congress that the amount of RMPs the agency requires should not be used as a performance measure, Pitts said.

RMP meetings between the FDA and industry are considered part of the current PDUFA process. Congress must reauthorize PDUFA by Oct. 1, 2007.

The agency may also be using this concern about RMPs to head off lawmakers’ efforts to establish a new FDA drug safety office, by arguing that more collaboration, rather than further prescriptive approaches, is the right way
to go to increase safety, Pitts added.

But another industry source does not believe Gottlieb’s comments necessarily represent a new agency position. Gottlieb discussed many topics during the speech, including a balanced view about the importance and drawbacks of RMPs, Sara Radcliffe, the Biotechnology Industry Organization’s managing director of science and regulatory affairs said. Arguing that the portion of Gottlieb’s speech where he states his concerns with RMPs represents a change in the FDA’s view may be “reading too much into it,” she added.

The AP headline reads:

“Number of seniors with drug coverage down”

Here’s the first paragraph:

WASHINGTON (AP): About 500,000 fewer Medicare beneficiaries have prescription drug coverage than the federal government originally projected this month.

But here’s the story:

The drop occurred because many of the 3 million beneficiaries being counted as getting coverage through the Veterans Affairs Department had switched over to a private plan under Medicare Part D, so they were being counted twice, said Mark McClellan, administrator for the Centers for Medicare and Medicaid Services.

So, in fact, the number of seniors with drug coverage is NOT down.

Oops.

But, as usual, Mark McClellan — the hardest working man in health care — puts the story in the proper perspective:

McClellan said the new numbers reflect that the Medicare program was more popular with veterans than had been anticipated. When VA officials ran final numbers after the May 15 enrollment deadline, they found that about a third of those seniors participating in VA drug coverage had enrolled in a private plan under Medicare Part D.

And, at the end of the day, according to the story:

… the new numbers do little to change the overall percentage of seniors with some insurance coverage for their medicine. About 90 percent have some coverage, either through Medicare or through another program, officials say.

Talk about Headline News!

Scott Gottlieb doesn’t just talk the talk..this is a guy who cares about patients and knows that physician discretion is still a primary source of medical innovation. And he knows that real risk management comes with integrating advanced technologies early in the drug development process, not burdening doctors and patients with paperwork as with the Tysabri risk management program…Read the article below as a great example of how Scott and FDA staffers are making a difference and why they deserve more time, money and resources to innovate:

FDA Official Questions Key Drug Safety Policy - 16 June 2006 Drug Industry Daily - By Stephen Langel

The FDA is growing increasingly concerned about its own practice of requiring companies to provide risk management plans (RMPs) as a condition of drug approvals, a high-ranking agency official said.

The FDA believes that RMPs, while important in some instances, may be too prevalent, Scott Gottlieb, the agency’s deputy commissioner for medical and scientific affairs, said in a speech before the American Medical Association. As the requirement for RMPs becomes more pervasive, the burdens could become too much for physicians and their patients, he said during the June 12 speech. “I worry about the future,” he said.

An RMP is a method the agency uses to assess the risks and benefits of a drug and minimize the risks while maximizing the benefits. But Gottlieb believes these plans — which many times include physician training programs for proper use of the drug, public notices about its dangers and drug registration programs could become too much of a burden and restrict doctors’ discretion.

“The more we promulgate plans that attempt to guide or even control [medical] decisions, the more we encroach on professional autonomy,” he said. This is especially problematic when busy clinics do not have the time to go through the various steps these plans require, he added.

Industry groups such as PhRMA have also expressed concerns with the burden RMPs can represent. The group has argued that while it supported the idea of RMPs, the agency needs to ensure that they do not impose overwhelming burdens on the medical community. “Care must be taken not to overburden the healthcare system by using too many resource-intensive tools in RMPs,” the group said in a risk management presentation.

Both the FDA and the medical community are to blame for this trend, Gottlieb told DID in a follow-up interview. While doctors have not always done everything possible to police themselves, the agency has not always created opportunities for physicians to be involved in ensuring safe drug use, he said.

The agency believes that greater cooperation between the FDA and the medical community is the solution. “I believe some of the same safety goals embodied in the RMPs could be achieved if we had more ability to collaborate more closely and effectively with physician organizations,” he added.

To reach this goal the agency is working to establish an office that will ensure more regular collaboration and communication about clinical issues with medical organizations, Gottlieb said. Terry Toigo, the agency’s acting associate commissioner for external relations is heading the team that is developing this new office, he added.

Gottlieb raised his concerns at a time when the agency has made RMPs a common requirement in granting drug approvals. For example, the FDA recently allowed multiple sclerosis drug Tysabri to be sold after the product was pulled from the market, but only if the company provided an RMP (DID, June 6).