Latest Drugwonks' Blog
From the pages of the New York Times …
Label Updates May Be Allowed for Generics
By KATIE THOMAS
The Food and Drug Administration proposed a rule on Friday that would permit generic drug makers to update their labels if they received information about potential safety problems. The move puts the companies on equal footing with brand-name manufacturers, but it also opens the door to lawsuits against them for the first time since the Supreme Court barred such cases two years ago.
Until now, only brand-name drug makers had the ability to independently update their labels if important new information surfaced about one of their drugs. If the F.D.A. agreed that the new information warranted a change in the label, then generic companies were required to update their product information so that it would be identical to the branded drug’s labeling.
Dr. Janet Woodcock, the F.D.A.’s head of drug evaluation and research, said the proposed change would create better parity between brand-name drug manufacturers and generic companies, which is especially important given that more than 80 percent of prescriptions in the United States are currently dispensed as generic drugs. “Now, with the generic industry having grown up, most people are taking generic drugs,” she said in a telephone interview. “It’s really time to level the playing field.”
The rule would also pave the way for lawsuits from patients who could now claim that generic companies did not sufficiently warn them of a drug’s dangers. In 2011, the Supreme Court ruled that such lawsuits were not valid because generic companies were required to use the same label warnings as brand-name manufacturers and thus could not be blamed for failing to warn patients about the risks of taking their drugs.
Consumer advocates, who have long called on the agency to make such a change, praised the decision because they said the current situation was unfair to patients harmed by generic drugs.
“This is an important consumer protection provision,” said Representative Chris Van Hollen, Democrat of Maryland, who had supported such a change. “It’s a long time in coming.”
The Generic Pharmaceutical Association, the industry trade group, said it was still reviewing the regulation but was concerned that the change could create confusion. In a statement, Ralph G. Neas, the association’s president, said the group was “very concerned that multiple versions of critical safety information would lead to unnecessary confusion and uncertainty for prescribers and other health care professionals, with harmful consequences for patients.”
Mr. Neas also raised the question of whether the rule was legal. “The Supreme Court has repeatedly held that generic pharmaceutical manufacturers must duplicate the language on the brand pharmaceutical manufacturer’s labels and cannot make changes to a label without F.D.A. approval,” he said in the statement. “Therefore, the agency’s authority to enact a rule that differs from the federal law is unclear.”
The proposed rule, which is open to public comment for 60 days, would set up a website that would place all updates for a given drug in one place, minimizing such confusion, Dr. Woodcock said.
The agency said the Supreme Court decision, Pliva v. Mensing, altered the incentives for generic drug companies to conduct adequate monitoring of their drugs because it eliminated the threat of lawsuits from patients who were harmed by those products. In proposing the rule, the agency said it “intended to ensure that generic drug companies actively participate with F.D.A. in ensuring the timeliness, accuracy and completeness of drug safety labeling.”
Dr. Woodcock said she did not expect that generic companies would update their labels frequently, because by the time drugs become available as generics, they have been on the market for years. “It’s not to say that we won’t learn new things, but it becomes less likely to come across new serious adverse events,” she said.To address (one hesitates to say “celebrate”) American Diabetes month, here is the latest addition to Pfizer’s Value of Medicines series -- The Value of Medicine for Type 2 Diabetes.
The development of medicines is complicated -- explaining their value should not be. Pfizer's straightforward efforts put the facts in perspective -- and in plain English. Their Value of Medicines series provides highly valuable tools for healthcare policy professionals, practitioners, and patients. Additional materials can be found here.
Knowledge is Power.
From the pages of the Oregon StatesmanJournal
From Eugene to Eugenics: Oregon's new cost-cutting strategy is to deny care to cancer patients
In an ad for the Affordable Care Act, local folk singer Laura Gibson plucks her guitar and muses about how the “Oregon way” is to “care for each one, every daughter and son.” Though a little corny, the song delivers a worthy message: Oregon is committed to providing everyone access to health care.
The commercial is part of Oregon’s new ad campaign to boost enrollment in the newly created “Cover Oregon” health insurance exchange.
But the reality strums a different, far less organic tune. Even as Oregon drops $3.2 million to spread their “each one” message, the Beaver State is also taking measures to that would deny life-saving treatments to desperately sick citizens.
In August, Oregon’s Health Evidence Review Commission issued an update to its guidelines for providing cancer treatment to low-income individuals covered by the state Medicaid program. These new guidelines require that Medicaid deny coverage for certain cancer treatments for patients that have been deemed “too” sick, haven’t responded well to previous treatments, or can’t care for themselves.
Through these new rules, Oregon state bureaucrats are severely restricting access to care and dooming potentially thousands of local patients to a premature death.
What’s worse it that these new Medicaid guidelines are not grounded in the medical literature or best clinical practices, according to Kenneth Thorpe, chairman of the Partnership to Fight Chronic Disease. Rather, according to Thorpe, they’re based “on the odds of survival observed in a group of patients.”
It’s true that for some late-stage cancer patients, the odds are long than any additional treatment can help. But without access to the latest that medical science has to offer, a patient’s survival rate simply drops to zero.
As B.J. Cavnor of the Northwest Patient Education Network powerful puts it: “Cutting patients off from cures means patients who could have beaten their illness will no longer have that chance.”
It’s a frightening move from Eugene to eugenics. These guidelines dictate that Medicaid only provide “palliative” care – painkillers, acupuncture treatments, wheelchairs, drugs for nausea, and the like.
So while Oregon won’t let Medicaid patients have access to cancer medicines that could prolong or save their lives, it will pay to make their deaths slightly less painful. Is that what Oregon considers compassionate care?
About 19,000 Oregonians are diagnosed with cancer each year. Over 640,000 state residents are covered by Medicaid -- that’s about one in five of the total state population. And the state Medicaid ranks will swell next year, when the Affordable Care Act will raise the program’s income threshold up to 138 percent of the federal poverty line.
Oregon’s new Medicaid guidelines take treatment decisions out of the hands of doctors and patients and put them in the hands of distance state bureaucrat willing to cut costs no matter the human toll. It’s the practice of cost-centric controls over patient-centric care.
Even supporters of the President’s healthcare law have taken to calling these treatment restrictions a death knell for poor cancer patients.
Cavnor, the patient advocate, has described them as “extremely frustrating and morbidly ironic, especially for those of us who have tried to argue that the Affordable Care Act doesn’t allow for ‘death panels.’”
Is this really change we can believe in? Promising to expand access to health care to all while denying it to those who need it most is brazen hypocrisy. Oregon should expect more from itself.
At the end of her song boosting the state’s health exchange, Laura Gibson sings “live long, Oregon.” That’s a good aspiration. Oregon’s state bureaucrats should live up to it.
Peter J. Pitts, a former associate commissioner at the FDA, is president of the Center for Medicine in the Public Interest.
Substandard Subcontinent.
On its Tuesday broadcast, the CBS Evening News reported on former Ranbaxy executive Dinesh Thakur, who “was asked by his boss to investigate allegations of fraud at the company” in 2004. He soon “uncovered disturbing problems with the data required by the FDA to prove the effectiveness of Ranbaxy drugs.” According to Thakur, the company had “gotten approvals from the FDA to sell drugs that were based on no data, or data that was fraudulent.” After presenting his finding to Ranbaxy executives in 2005, Thakur “says nothing was done,” so he “blew the whistle to the FDA.”
The CBS News website reports the FDA investigation uncovered a “persistent ... pattern” by Ranbaxy of submitting “untrue statements.” Auditors found that the applications of at least 15 new generic drugs contained over 1,600 data errors, leading the FDA to conclude the company’s products were “potentially unsafe and illegal to sell.” The investigation that was launched in the wake of “Thakur’s allegations led Ranbaxy to plead guilty to seven felonies.”
I’ve just returned from Kiev, Moscow, and Algiers where I spoke on pharmaceutical quality, bioequivalence, and generic interchangability. (And, yes, I did get a chance to tour around a little too.)
Two comments worth sharing.
* In Algiers, the head of the domestic generic drugs manufacturers, told me that the issues of generic quality and therapeutic substitution were “obsolete.” It was a laugh line – because that’s how the audience responded.
* In Moscow, at a meeting of federal and provincial healthcare officials, one comment (relative to patient choice vs. limited formulary options) was, “The only patients who give us trouble are those who want more expensive treatments.”
In Russia -- if you like your insurance, you can keep it. If you don't like it, you can keep it ... quiet.
Think of it as a healthcare safety nyet.
The themes for the Algerian Society of Pharmacy’s 22nd Journées Pharmaceutiques Nationales was health policy , intellectual property , self-medication and hospital pharmacy. A panel of national and international experts addressed the generic drugs and the pharmaceutical industry in Algeria.
According to Prof. P. J. Pitts , president of the U.S. Center for Medicine in the Public Interest, "We cannot replace quality with cost. Even a high quality generic does not always give the same therapeutic effect as the innovative product . The authorities should work with physicians and pharmacists to ensure that patients remain at the center of debate. The most expensive drug is the one that does not work. The most effective treatment is one that delivers good patient outcomes," he said.
The President of the National Council of the Order of Pharmacists , Dr. Lotfi Benbahmed, insisted on continuing education for pharmacists and also the establishment of a system to determine the traceability of drugs to determine responsibility.
"The door is open to counterfeiting and quackery. It is a great danger to public health if official medication is not controlled."
The complete article (in French) can be found here.
A small item from BioCentury that deserves more attention:
Drug companies will be able to provide copay assistance to consumers who purchase health insurance through the Affordable Care Act's exchanges. HHS Secretary Kathleen Sebelius announced the decision in a letter sent on Wednesday to Rep. Jim McDermott (D-Wash.), resolving a major uncertainty about the healthcare law. Under federal kickback laws, drug companies are not permitted to provide copay assistance directly to consumers insured by federal programs such as Medicare and Medicaid. According to Sebelius' letter, HHS does not consider qualified health plans purchased through federal or state exchanges to be federal health programs.
Washington, DC—HR Policy Association, representing the chief human resource officers of more than 350 of the largest private sector employers in the United States, announces the selection of Tevi Troy, former Deputy Secretary of the U.S. Department of Health and Human Services, to lead the development of a health care initiative of the HR Policy Foundation.
HR Policy Association member companies, all of whom are large employers, collectively spend more than $75 billion annually on health care in the U.S. and are in the process of assessing their company's current and future health care strategies in light of the growing instability of the American health care system. They are seeking to establish a leadership organization dedicated to developing a more sustainable health care delivery system for the employees, dependents and retirees of large employers.
Dr. Troy is currently a Senior Fellow at Hudson Institute, where he will remain an Adjunct Fellow, and a writer and consultant on health care and domestic policy. In 2007, he was unanimously confirmed by the U.S. Senate as the Deputy Secretary of the U.S. Department of Health and Human Services. He was the chief operating officer of the largest civilian department in the federal government, with a budget of $716 billion and over 67,000 employees. In that position, he oversaw all operations, including Medicare.
HR Policy Association CEO Jeffrey C. McGuiness said, “We are delighted to announce that Dr. Troy will be leading this critically important initiative. He brings not only a wealth of understanding and expertise about health care, policy and the government, but a strong managerial and operations background. Having successfully run the largest department in the government in terms of employees and budget, focused on all aspects of health care, Dr. Troy is uniquely qualified to help guide and lead this new organization.”
Dr. Troy has extensive White House and Capitol Hill experience. During the George W. Bush Administration, he served as Deputy Assistant and then Acting Assistant to the President for Domestic Policy and was the White House’s lead adviser on health care, labor, education, transportation, immigration, crime, veterans and welfare. Dr. Troy also served as the Policy Director for U.S. Senator John Ashcroft and as Senior Domestic Policy Adviser and Domestic Policy Director for the U.S. House Policy Committee.
In addition to his senior level government work and health care expertise, Dr. Troy is also an author and presidential historian. He is a frequent television and radio analyst, and has appeared on CNN, CNBC, FOX News, FOX Business, and The Jim Lehrer Show, among other outlets. He is currently on tour for his latest book, What Jefferson Read, Ike Watched, and Obama Tweeted: 200 Years of Popular Culture in the White House and is the author of Intellectuals and the American Presidency: Philosophers, Jesters, or Technicians? (Lanham: Rowman & Littlefield, 2002). He has written over 100 articles, for The Wall Street Journal, The Washington Post, Forbes, The New Republic, Commentary, Reason, Investor’s Business Daily, National Review, Washingtonian, The Weekly Standard, and other publications. Dr. Troy has a B.S. in Industrial and Labor Relations from Cornell University and an M.A and Ph.D. in American Civilization from the University of Texas at Austin.
I'm in town to give a presentation on the importance of API and excipient quality, the urgency of advancing pharmacovigilance, and the evolution of both regulatory innovation and international regulatory fraternity.
The local english-language newspaper is The Moscow Times. It's what you get at the hotel. And amidst all the stories on NSA wire-tapping was an editorial that nearly made my heart stop. The title, "Dispelling the Smoke Screen." Here's the opening paragraph:
"The statement that smoking is harmful to your health is only a theory, not a medical fact."
Don't believe me? Read the article and then exhale. And then get angry.
This in a nation where non-communicable diseases (most notably alchohol and heart disease) are major killers. 50% of Russians smoke cigarettes.
I intend to discuss this article during my presentation.
Outrageous!
Check out Pfizer’s new “Value of Medicines: How Medicines Have Changed Our World” position papers. They’re actually concise and to the point (unlike many of the policy papers we see these days).
At the moment there are three to choose from:
* The Value of Statins
* The Value of Oncology Medicines
* The Value of Adherence
They can all be found here.
According to the website, “Papers will soon be available demonstrating value in a variety of areas including Vaccines, Diabetes, Rare Diseases, Atrial Fibrillation-Stroke, Pain, Renal Cell Carcinoma, Smoking Cessation, Breast Cancer, and more. Stay tuned!”
Kudos to Ian & Company for a job well done.
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.
