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FDA NEWS RELEASE

For Immediate Release: June 10, 2011
Media Inquiries: Morgan Liscinsky, 301-796-0379,
morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves redesigned labels for some Merck drugs
Changes developed under Merck’s Label Standardization Project

The U.S. Food and Drug Administration today is announcing the approval of Merck’s redesigned drug container labels that include a new standardized format to improve readability and provide better information on product and strength differentiation.

Merck’s Label Standardization Project includes the revision of 34 container labels for 16 solid oral drug products regulated by the FDA’s Center for Drug Evaluation and Research (CDER). Drugs affected by the revisions include: Cozaar, Crixivan, Hyzaar, Isentress, Janumet, Januvia, Mevacor, Noroxin, Prinivil, Prinizide, Propecia, Proscar, Singulair, Zocor, and Zolinza.
 
“We commend Merck for their efforts,” said Janet Woodcock, M.D., director of CDER. “This was no small undertaking, and we are hopeful that Merck’s new standardized labels will aid in reducing pharmacy selection errors.”

Merck's project included evaluating the proposed label content and layout, selecting new packaging design, and obtaining regulatory approval to implement the new packaging design. The Label Standardization Project process included:

  • a scientific approach to label design through Human Factors Engineering and Usability Studies
  • incorporation of feedback received from the FDA and from label surveys
  • a bundled supplement regulatory approach to ensure that labels were acceptable across CDER’s eight clinical divisions.

To better access the impact of these label changes, the FDA encourages health care providers to report medication errors related to the products included in Merck's Label Standardization Project to MedWatch, the FDA’s adverse event reporting program.

The bad news is that safest place to be in Washington these days is between Chuck Schumer and the facts about Part D.  Safe -- because it’s the path less traveled. Bad news because he has recently begun trumpeting the need for government price controls and extended rebates for duel eligibles as the “solution” to increased Medicare spending.

New York’s senior senator is living in talking point fantasyland.

The good news is that accumulating evidence shows that Part D is succeeding beyond all expectations, delivering needed prescription drugs to Medicare beneficiaries for less money than anyone expected—driven by strong competition among plans.

Consider:

Current CBO Estimates Show Part D Is Costing Far Less than Initial Estimates 

* The 2011 CBO Medicare Part D baseline forecasts and actual recorded spending show costs for Part D benefit payments have declined by 46%, for the 2004 to 2013 period compared with initial estimates of the 10-year cost projections for those years.
[i]

* Also this year, CBO reduced its baseline 10-year spending projections for all of Medicare by $186 billion, mostly due to lowered drug spending forecasts. CBO cites that “[a]pproximately two-thirds of the change comes from reducing the projected growth rate for Part D (prescription drug) spending per enrollee on the basis of an updated analysis of national trends in spending for prescription drugs.”[ii]

Part D Plan Bids Declined, Even as the Value of the Benefit Increased


The Affordable Care Act (ACA) significantly enhanced the value of Part D benefits by providing:

* a one-time $250 tax free check for beneficiaries with any spending in the gap in 2010

* a 50% discount on branded drugs while in the coverage gap beginning in 2011; and

* a phased-in closing of the remaining coverage gap by 2020 for both brand and generic drugs.


Despite these significant enhancements to the value of the benefit, Part D plan bids, for which plans need to be accurate since they are at risk, decreased for the 2011 plan year. According to CMS, the Part D National Average Monthly Bid Amount for 2011 is $87.05, a decrease of $1.28 (or -1.4%) compared with the 2010
ii] Further, the Medicare Trustees estimate that “[f]or 2011 and beyond, the bids are projected to ultimately converge to between 1 and 2 percent lower than actual spending due to aggressive plan bidding.v]

Medicare Trustees Find Continued Robust Negotiation of Drug Rebates by Part D Plans

I
n analyzing Part D spending, the Medicare Trustees cite significant levels of rebates across the universe of drugs in the program, including brands and generics. In 2011 the Trustees reported, “rebates for 2009 were approximately 11.1 percent of total prescription drug costs, which was somewhat higher than the plans estimated in their bid submissions. However, some of the drugs with the highest Part D rebate amounts will be losing patent protection in the next several years. As a result, rebates are projected to decrease from 10.7 percent in 2010 to 9.7 percent in 2020.”[v]

The Trustees clarify that the reported rebate levels “are average rebate percentages across all prescription drugs. Generic drugs, which represent about 72 percent of all Part D drug use in 2009, typically do not carry manufacturer rebates. Many brand-name prescription drugs carry substantial rebates, often as much as 20-30 percent.”[vi]

Recent Research Shows that Competition among Part D Plans Lowers Drug Spending in the Private Sector
 

Economists from the University of Southern California and Boston University have found that because Part D resulted in more people being covered by private insurance plans, the plans’ negotiating powers were increased such that “[o]n average, Part D lowered retail prices for commercial insureds by 5.8% to 8.5%. The cost-savings to the commercial market amount to $3 billion per year, which approximates the total annual savings experienced by Part D beneficiaries who previously lacked drug coverage.”[vii]

Average Beneficiary Part D Premiums in 2011 Are 43% below Original Projections


The average monthly beneficiary premium for Part D coverage will be $30 in 2011, far below the $53 forecast originally, and an increase of only $1 over the 2010 average premium of $29. According to CMS Administrator Don Berwick, “[t]hese very modest increases in premiums, along with the new discounts...are going to make medications more affordable to Medicare beneficiaries”[viii] CMS officials report that in 2011, over 99% of Part D enrollees will have access to a plan with a premium that is the same or lower than their 2010 premium.[ix]

Beneficiaries Are Highly Satisfied with Part D


Recently released polls show that Medicare Part D enrollees are overwhelmingly satisfied with their Part D coverage. It shows 84 percent of Part D enrollees are satisfied with their coverage, and 95 percent say their coverage works well. Additionally, vulnerable beneficiaries who are dually eligible for both Medicaid and Medicare exhibited the highest satisfaction.[x]

Senator Schumer should check the facts before he points the finger.



[i] See CBO Medicare baselines for 2005 through 2011 available at www.cbo.gov

[ii] CBO, “Preliminary Analysis of the President’s Budget for 2012,” March 18, 2011, p. 12. http://www.cbo.gov/ftpdocs/121xx/doc12103/2011-03-18-APB-PreliminaryReport.pdf

[iii] See: CMS Office of the Actuary memo, “Release of the 2010 Part D National Average Monthly Bid Amount,” August 13, 2009, CMS Office of the Actuary memo, “Release of the 2011 Part D National Average Monthly Bid Amount,” August 18, 2010. Both memos available at found at http://www.cms.gov/MedicareAdvtgSpecRateStats/RSD/list.asp.

[iv] 2011 Medicare Trustees Report, p. 184.

[v] 2011 Medicare Trustees Report, p. 183.

[vi] 2011 Medicare Trustees Report, p. 183. Footnote 76.

[vii] Lakdawala, D. and Yin, W. “Insurers’ Negotiating Leverage and the External Effects of Medicare Part D” NBER Working Paper 16251. August 2010, www.nber.org/papers/w16251.

[viii] CMS Press Release, “Medicare Prescription Drug Plan Premiums to Increase Slightly Medicare Beneficiaries May Need to Enroll in New Plans,” August 13, 2009.

[ix] MedPage Today, “Medicare Part D Premiums Going Up by $1 in 2011,” Emily P. Walker, August 19, 2010.

[x] [x] KRC Survey for Medicare Today, “Seniors’ Opinions About Medicare Rx: Fifth Year Update” September 2010.

Warning Shot

  • 06.12.2011
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From the pages of the New York Times:

Letter


Warning Labels on Drugs
June 10, 2011

To the Editor:

Side Effects? These Drugs Have a Few” (Week in Review, June 5) rightly ridiculed the growing number of warning labels on prescription drugs. But it’s the Food and Drug Administration’s job to promote the safe and effective use of medications and medical technology.

Unfortunately, the current liability system encourages well-financed tort lawyers to view new product warnings or withdrawal decisions as signals to file lawsuits in hopes of securing a quick payday. Such irresponsible litigation doesn’t make America’s health care system safer — it just helps a small number of lawyers get rich.

PETER PITTS
New York, June 6, 2011

The writer is president of the Center for Medicine in the Public Interest and a former F.D.A. associate commissioner.

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According to Politico, “Consumer advocates are blasting the FDA for the process it has used to renegotiate the terms of the drug approval process following news that a deal has been reached with industry on proposed changes to the process.”

The FDA had been holding two sets of meetings in working out an agreement on the Prescription Drug User Fee Act, which Congress must reauthorize in 2012. One set has been held with representatives of PhRMA and the Biotechnology Industry Organization, the other with stakeholders including patient groups, consumer advocates and provider organizations.

According to an email obtained by POLITICO, industry accepted an FDA proposal “shortly before Memorial Day weekend” and forwarded an agreement to HHS last week. But stakeholders did not receive details on the deal until Wednesday morning. The email, which was forwarded to POLITICO by a source, was sent by Theresa Mullin, the Director of the Office of Planning and Informatics in the FDA Center for Drug Evaluation and Research.

 “I was not surprised that we were left in the dark,” said one rueful consumer advocate participating in the stakeholders’ meetings on background. “We went through the motions but the real deal was over there with industry and the process was opaque.”

FDA spokeswomen Karen Riley declined to comment on any of the specific details of this process.

"The package of proposed recommendations is currently undergoing further administration review and that we cannot comment on the details of the package," Riley wrote in an email back.

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From MedPage Today:

FDA Touts New Adverse Reporting Rule
By John Gever, Senior Editor,
 
FDA officials took to the pages of the New England Journal of Medicine to highlight the agency's new system for reporting adverse events in clinical trials, which they hope will make such reports less numerous but more useful.
 
In an online Perspective article published Wednesday in the NEJM, Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, and other top CDER officials explain the rationale for the new regulation, which was announced in September 2010 and implemented this past March.
 
The new system shifts primary responsibility from individual investigators to trial sponsors for determining when adverse events seen in a clinical study are potentially related to the investigational drug, Woodcock and colleagues indicated.
 
At the same time, individual investigators will be required to report every adverse event to the trial sponsor.
 
Under the old system, sponsors were required to report to the FDA every individual adverse event that they knew about in a trial, irrespective of whether the trial drug may have been responsible.
 
But the individual investigators did not have to report every adverse event they saw to the sponsor. Instead, they were required to report only those events they believed were "probably" related to the trial drug.
 
This system misplaced the responsibility, because site investigators are in a relatively poor position to make such determinations, wrote Woodcock and colleagues.
 
"It's difficult ... for an investigator to attribute a serious adverse event to a drug on the basis of an isolated incident, and individual investigators often do not have timely access to the entire safety database," the officials argued.
 
Instead, they said, trial sponsors should be the ones to determine when adverse events are drug-related, and site investigators should report to the sponsors every serious adverse event they see.
 
"Causality of adverse events is best evaluated in the aggregate by the sponsor," according to the FDA officials.
 
Moreover, the only adverse event reports the agency wants to receive are those describing "serious, unexpected, suspected adverse reaction[s]," Woodcock and colleagues wrote. They suggested that episodes of Stevens-Johnson syndrome would likely qualify, since the condition is known to be associated with drug exposures and is highly unusual otherwise.
 
On the other hand, a stroke occurring in an elderly patient would not be unexpected and would seldom be a drug reaction.
 
The new regulation instructs sponsors not to report individual events like these that would be expected in the study population anyway, or that were prespecified endpoints in the trial.
 
In the past, the FDA received many such individual reports, and it could hardly ever make use of them.
 
"Large numbers of such uninterpretable single case reports can distract clinical investigators, the FDA, and IRBs from recognizing genuine drug-safety problems," Woodcock and colleagues wrote.
 
"The FDA expects that this new approach will reduce reporting-data noise that may mask true signals of significant adverse events, so that what is reported to the FDA, clinical investigators, and IRBs will be more meaningful and relevant to patients' safety," the officials wrote.
 
They added that trial sponsors are still expected to monitor and report nonserious adverse events as they have done in the past.

When sponsors do become aware of serious and unexpected events in a trial, the regulations give them 15 days to inform the FDA -- or seven days if an event is fatal.
 
 
 

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Terrance Scanlon, president of Capital Research Center, notes that even in the wake of the Wakefield fraud Jenny McCarthy’s anti-vaccine zealotry is as strong as ever.
 
The anti-vaccine hysteria that McCarthy has helped to whip up has already claimed the lives of more than 700 children, according to the website JennyMcCarthyBodyCount.com. That website relies on data from the Centers for Disease Control that show that between June 2007 and May 2011 there were 78,981 preventable illnesses and 727 preventable deaths of children who could have been vaccinated but weren’t.

Danielle Romaguera of New Orleans told science writer Michael Fumento of her daughter Gabriella, who died of whooping cough when she was just a month old. That’s too young for a baby to be vaccinated. But because other children did not get their shots, whooping cough, once nearly eradicated, is reappearing in cities like New Orleans.

“People need to know they can infect other parents’ babies,” Romaguera said. “It kills. People think these diseases don’t exist anymore but that’s because children are being vaccinated.” Romaguera added that “our pediatrician says parents tell him all the time they don’t care what the science says. And because of it, babies and kids are dying.”

Scanlon concludes by asking: How high will the body count have to rise before McCarthy and her supporters realize that refusing to vaccinate children does more harm than good?

That’s one question we can be sure Jenny McCarthy and other anti-vaccine adherents will never answer.

Mr. Scanlon’s full piece is well worth a read.

Terrific review of PDUFA V (via BioCentury’s always insightful Washington Editor, Steve Usdin), “PDUFA:  A lot of talk.

The selected verbiage below is from Mr. Usdin’s article – the subheads are not.

Thy rod and thy staff, they comfort me

High quality reviews performed on a predictable timetable has been the industry’s primary objective for PDUFA since the program’s inception in 1992. But as user fees have exploded over the decades and have been allocated to a widening range of activities, success in achieving their principal goal has been elusive. FDA has consistently managed to approve about 60% of priority NDAs for new molecular entities (NMEs) and original BLAs within a single review cycle, but has done so only by pulling staff away from standard reviews.

The 33 1/3rd % Solution

Although about 80% of all NDAs and BLAs are eventually approved, there has never been much more than a one-in-three chance that a standard NME or BLA would be approved in the first cycle.

Subjective Meeting Objectives Meetings

To increase first-cycle approval performance, the PDUFA V agreement adds a two-month “filing period” to the start of the review process for NME NDAs and original BLAs, establishes a mid-cycle meeting to allow sponsors to attempt to get errant reviews back on track, and sets up a late-cycle meeting to smooth any advisory committee meetings or negotiations over labels or risk evaluation and management strategies (REMS).

In addition to improving communications with sponsors, the agency plans to create new fora for patients, along with formal procedures for integrating patient perspectives into review criteria.

According to CDER Director Janet Woodcock, “I would like to pursue patient-centered drug development where the regulators and the developers really understand where the patients are coming from in that disease,” She said that “no one, the medical profession or the FDA, has done a good enough job listening from the patients how drugs feel to them and how they feel about benefits and risks.

The BRAT Pack

Woodcock added that FDA is developing a semi-quantitative benefit-risk framework that will “standardize how we think and talk about benefits and risks and residual uncertainty,” and that the agency plans to make it part of the review process during PDUFA V.

Begging the question – or just begging?

The industry also has agreed that FDA can use PDUFA money to hire over 10 staff to bring new scientific expertise into the agency. Nevertheless, the total tab for PDUFA V over five years is expected be about $3 billion, compared to $2.9 billion for PDUFA IV. Thus the begging question will be whether the added review time and communications commitments, rather than money, will achieve the kind of agency performance that has not been reached in prior user fee agreements.

Unpresent Danger

Moreover, the agency’s Office of Surveillance and Epidemiology (OSE) has not been present in the negotiations, which could be a sign the agreement will not resolve poor coordination and bureaucratic in-fighting.

A Mighty Minyan

Industry agreed to pay for 10 FTEs to implement the enhanced communications program, as well as $100,000 annually for internal training and industry outreach. FDA has agreed that the “liaison staff. The new liaison staff will “serve as a point of contact for sponsors who have general questions about drug development or who need clarification on which review division to contact with their questions,” according to the goals letter.

Better Late Than Never

PDUFA V also will add a late-cycle meeting for new molecular entity NDAs and new BLAs that is intended to be a comprehensive assessment of the agency’s review, including descriptions of issues that might be raised at an advisory committee meeting.

The late-cycle meeting addresses complaints from sponsors that they have learned about critical issues FDA will raise with an advisory committee only a few days before the meeting, and that often companies learn about agency concerns for the first time in a complete response letter.

For applications that will be discussed by an advisory committee, the late-cycle meeting will occur at least 12 calendar days before the panel meets. FDA will provide the sponsor with a draft of the questions the agency plans to ask the committee.

The Lords of Discipline (Letters)

FDA has stated it will provide the briefing package at least 20 calendar days prior to a scheduled advisory committee meeting and at least 12 calendar days prior to the late-cycle meeting if a panel meeting is not planned. FDA told industry it aims to have “discipline review” letters ready in advance of the late-cycle meeting. Discipline review letters note any deficiencies in specific sections of applications, such as the clinical, chemistry, manufacturing and controls, non-clinical pharmacology and toxicology, and the human pharmacokinetics and bioavailability sections.

A New Broom?

In the end, FDA and the industry groups agreed on a sweeping policy that applies to all companies and is intended to make the drug review culture more interactive and collaborative.

Amen.

When PMI is TMI

  • 06.06.2011
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Ah, the brief summary.  Inside the FDA many joke that it is like the Holy Roman Empire – neither brief nor a summary.  And if you want to throw in “fair balance and adequate provision,” well, go right ahead.  Same issue – too much information equals not enough comprehension.

It’s not a new problem. FDA took a crack at addressing it in January 2004 with a draft guidance on new ways to approach the brief summary.  (I was proud to have been part of that effort.) Then, in January 2006, came the agency’s New Labeling Rule – an attempt to make the PI more user-friendly (the “user” being the physician). More recently the FDA has launched its "safe use" initiative, trying to reconfigure patient medical information (PMI) in more potent and health literate ways to plural constituencies. To date, all of these efforts met with only modest success.

This is an important public health issue. (In 2006, Dr. Jerry Avorn and Dr. William Shrank of Harvard Medical School wrote a paper in The New England Journal of Medicine calling it “linguistic toxicity.”)

The issue comes front and center again in a short article that appeared in Sunday’s edition of the New York Times, “Side Effects?  These Drugs Have a Few.”

Some snippets:

Dr. Jon Duke of Indiana University was trying to figure out why his patient’s blood platelets were abnormal. Could it be a side effect of one of the dozen drugs the man was taking, a number that is not uncommon among elderly people?

He began reading the label of each and every drug. “I was just overwhelmed,” Dr. Duke said. The lists of possible adverse reactions went on and on. Now he knows why. In a new paper in the Archives of Internal Medicine, Dr. Duke and two colleagues report that the average drug label lists 70 possible side effects and some drugs list more than 500. “This was beyond even what I’d expected,” he said. 

For anyone who has ever had to watch an entire Flomax commercial, the listing of a drug’s side effects is almost a joke. But the question is, why does the list continue to grow?


That same year, the Food and Drug Administration suggested making labels clearer with a new format and advised drug makers: “Exhaustive lists of every reported adverse event, including those that are infrequent and minor, commonly observed in the absence of drug therapy or not plausibly related to drug therapy should be avoided.” 


But, Dr. Duke found, instead of decreasing in the years after the agency issued guidelines, the average number of side effects rose to 94, as compared to 67 for those whose labels predated the new format. Some potential complications are weird, like “compulsive gambling.” Others, like “nausea” are so common — it’s listed on 75 percent of drug labels — that they almost seem like a universal issue. 


Listing every inkling of an adverse reaction can help drug companies in lawsuits, Dr. Duke said. If someone sues about a side effect that is listed in the drug’s package insert, the company can say patients had been warned. 


The Pharmaceutical Research and Manufacturers Association says the companies are just complying with the F.D.A.’s requirement that they reveal all of a drug’s risks, “even if a clear causal connection between the medicine and the observed adverse event cannot be fully established,” a spokesperson for the group wrote in an e-mail. 


And the F.D.A., in an e-mail, said “extensive lists of rare and minor adverse events for which there are no data to support a causal relationship” are not useful. 


That last statement from the FDA is pretty quixotic when you consider both the volume of warning letters and their content. Perhaps the above e-mail hasn’t yet made it down to DDMAC.

But the big problem is that the current liability system doesn’t reward lawyers who focus on real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications and medical technology. More and more often, these “mass tort” firms specialize in taking a new product warning label or withdrawal decision by the FDA, and view it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American health care system.

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Join us in Geneva

  • 06.03.2011
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Chronic diseases such as cancer, heart disease and diabetes have overtaken infectious diseases as the biggest health problem facing developing countries.  While there are many cost-effective ways of tackling these diseases, they often require access to well-trained medical professionals and high quality health infrastructure - something that is sadly in short-supply in many parts of the world.

Please join us in Geneva for an important lunchtime conversation with Eric de Roodenbeke, Chief Executive of the International Hospital Federation. Dr. de Roodenbeke will address the challenges facing developing countries as they adapt to this new epidemiological landscape – and provide some context ahead of the UN Summit on non-communicable diseases in September 2011. 

 When: Wednesday 13th July, 12:45-2:30pm

Where: Hotel Intercontinental, Geneva

Buffet lunch will be included - attendance is free of charge

About Eric de Roodenbeke

Dr. de Roodenbeke is Chief Executive of the International Hospitals Federation, the global association of hospitals and healthcare associations. He has held senior positions in the World Health Organisation, the World Bank, and the French Ministry of Health.  He has extensive hospital management experience, gathered both in Africa and France, and has published widely on hospital organisation, health systems reform and health policy insurance and financing in developed and developing countries.

The e-vite (along with RSVP form) can be found here.

CMPI

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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