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-- House Minority Leader Nancy Pelosi
Meanwhile, Philip Klein reports on the new CBO cost projections for implementation of the health care law:
When President Obama was selling his health care legislation to Congress, he declared that “the plan I’m proposing will cost around $900 billion over 10 years.” But with the law’s major provisions set to kick in next year, a new analysis by the Congressional Budget Office projects that the law will cost double that, or $1.8 trillion.
What accounts for the dramatic difference? It’s true that at the time of passage, the CBO said the gross cost of the law’s provisions to expand insurance coverage would be $940 billion over a decade. But as many critics of the health care law pointed out at the time, this number was deceptive because it estimated spending from 2010 through 2019 even though the program's major spending provisions weren’t scheduled to go into effect until 2014. Effectively, the original estimate measured the cost of six years of Obamacare instead of 10.
Now, as implementation approaches, CBO has released projections for the 2014 to 2023 budget window — the first actual decade of Obamacare — and the gross cost projection is $1.8 trillion.
Read More & Comment...
Question: Who is supposed to benefit from “breakthrough designations?”
(Breakthrough status was created in the 2012 FDA Safety and Innovation Act as a way of speeding development of products showing a dramatic improvement over existing therapies.)
Well, as is so often the case, where you stand on this question depends on where you sit.
If you sit in Congress or at the FDA, the first and most important answer is patients.
If you sit in a boardroom the first answer is likely to be stockholders.
Both answers are important -- but which is more important?
The question is, where lies the real value of a breakthrough designation? There can be more than one winner – but there must be a primary focus.
According to the Pink Sheet, As the number of sponsors holding breakthrough designations grows, so are the questions from analysts and investors about the value of the emerging program.
Several companies were questioned during their first quarter earnings calls about the value of the designation and its potential impact on the associated products. However, company officials did not have much to say about the effects it could have on a development program.
Merck & Co. Inc. announced it had received a breakthrough designation for its anti-PD1 antibody lambrolizumab (for treatment of advanced malignant melanoma) on April 24.
On May 2, Bernstein Research analyst Tim Anderson observed that Merck officials “did not provide clear answers” about what breakthrough means and “in our view, this designation does not actually mean much.”
To patients? No. To investors. Now, to be fair, that’s their business. But it sounds awfully cold.
Leerink Swann analyst Seamus Fernandez, who also asked about the breakthrough program during the call, concluded that the designation has no real downstream value – stating that the Merck breakthrough announcement “on its own has no impact on our expectations for relative anti-PD1 market share across multiple tumor types.”
“Downstream value?” For who? A new therapy for advanced malignant melanoma has plenty of value … to patients.
The Pink Sheet: While the ultimate value of the designation has yet to be tested, some analysts are still seeing significance that the product was deemed a breakthrough aside from whether it will actually accelerate development.
Is this gaming the system? It certainly could evolve that way. If just getting the designation helps to bump stock price, will companies apply for breakthrough status regardless of whether or not it seems therapeutically appropriate? One need only study the benighted history of “accelerated approval” to be somewhat dubious of motivation.
And wither "Special Medical Use?"
Kudos then to John Leonard, AbbVie senior VP and chief scientific officer, who downplays the hype surrounding breakthrough status. He reminded analysts on its quarterly call that “it doesn’t necessarily predict a regulatory outcome, however, or accelerate the review,” but does allow an opportunity for good planning.
Thank you, John
Indian generics manufacturer Ranbaxy pleaded guilty on Monday to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the US department of justice.
The settlement is its largest-ever with a generic drugmaker over drug safety, according to the US government. It includes $150 million in payments for a criminal fine and forfeiture and $350 million in payments for civil claims.
Ranbaxy USA pleaded guilty to three felony counts related to the manufacture of drugs at two Indian locations that did not meet safety standards and to four counts of making material false statements.
In 2008, the FDA banned the company from selling about 30 drugs in the United States after it found manufacturing deficiencies at facilities in India. In 2009, the FDA had accused the company of falsifying data and test results in drug applications and halted reviews of drugs made at a plant in northern India.
The company has since grappled with other manufacturing problems. In November 2012 it recalled some generic Lipitor, known as atorvastatin, in the United States after certain batches were found to contain glass particles. It has since resumed manufacturing the widely used cholesterol lowering medicine.
Yesterday Republicans on the House Energy and Commerce Committee sent a letter to Food and Drug Administration Commissioner Dr. Margaret Hamburg asking for the agency to provide information on former Johnson & Johnson executive Dr. Leona Brenner-Gati's role at the agency and the circumstances surrounding her resignation on May 3rd.
The letter points out a number of discrepancies, including that despite the fact that between February and April, Dr. Brenner-Gati was listed as the FDA's Acting Deputy Commissioner for Medical Products and Tobacco on the agency's public calendar, she was not scheduled for any significant meetings. Moreover, although Brenner-Gati's name remained on the public calendar into April, and the FDA's Office of Medical Products and Tobacco website still listed her as acting deputy commissioner when it was updated on March 22, the agency's organizational chart began listing the position as vacant on March 4, according to the letter. Reuters adds that FDA spokesperson Erica Jefferson declined to provide comment on the letter.Read More & Comment...
Gianna Chien is somewhat different from all the other researchers reporting on their work today to more than 8,000 doctors at the Heart Rhythm Society meeting.
Chien's study found that Apple Inc.’s iPad2 can, in some cases, interfere with life-saving heart devices because of the magnets inside. Source: Gianna Chien
Chien is 14, and her study -- which found that Apple Inc. (AAPL)’s iPad2 can, in some cases, interfere with life-saving heart devices because of the magnets inside -- is based on a science-fair project that didn’t even win her first place.
The research offers a valuable warning for people with implanted defibrillators, which deliver an electric shock to restart a stopped heart, said John Day, head of heart-rhythm services at Intermountain Medical Center in Murray, Utah, and chairman of the panel that reviews scientific papers to be presented at the Denver meeting.
If a person falls asleep with the iPad2 on the chest, the magnets in the cover can “accidentally turn off” the heart device, said Chien, a high school freshman in Stockton, California, whose father is a doctor. “I definitely think people should be aware. That’s why I’m presenting the study.”
Trudy Muller, an Apple spokeswoman, declined to comment on the study in an e-mail, referring questions about the iPad2’s safety to its online product guide. The guide cautions users about radio frequency interference, suggests that patients with pacemakers keep the iPad at least six inches away and says they should be turned off in health-care facilities when instructed by staff or posted signs.
Medtronic Inc. (MDT), the leading manufacturer of defibrillators, said its testing hasn’t found any risks from iPad technology when used according to the manufacturer’s instructions. The Minneapolis-based company does tell patients to avoid placing any magnets near the area where their devices are implanted.Read More & Comment...
Via the Huffington Post …
The Wrong Way to Dispose of Drugs
In late April, towns across the country participated in National Prescription Drug Take-Back Day -- a nationwide event organized by the federal Drug Enforcement Agency. Local law enforcement personnel and community groups were on hand to collect and dispose of unneeded and expired prescription drugs.
Most of us don't think about the old pill bottles cluttering up our medicine cabinets. But there are actually some important safety, privacy and environmental issues surrounding the disposal of unused prescription drugs. In this respect, take-back events are worthy endeavors. But some lawmakers want to go farther and make take-back programs mandatory.
Alameda County, California, recently passed an ordinance that would do just that. The county's new law requires pharmaceutical companies to develop, manage and pay for a new local drug take-back program.
There's good reason to believe very few people will participate in this program. It is also likely to result in higher drug prices and will produce few environmental benefits.
The driving force behind the take-back programs is concern for the environment. But less than 10 percent of pharmaceutical contamination is the result of improper disposal of unused medications. The vast majority of pharmaceutical contamination results from drugs being excreted by humans into waste water -- a problem take-back programs obviously can't address.
Encouraging proper household disposal is a superior approach to tackling this problem. Trash collected from homes is usually incinerated or put into double-lined municipal landfills equipped with collection systems that keep medicines from leaching into the ground.
Consumers do need to be educated about the risks of drug disposal. For instance, some people still improperly dispose of drugs in the sink or flush them down the toilet. In general, unneeded prescription drugs should be crushed, put in bags with sawdust, kitty litter or other fillers that make them unappealing to pets and children, and then thrown out in the trash. For privacy, bottle labels should be removed and destroyed before disposal.
Home disposal also avoids the dangerous "concentration" of pharmaceuticals. When many drugs are collected all at once, there's a greater risk they will be stolen or otherwise improperly used.
Alameda's law explicitly prohibits drug makers from charging any extra fees to pay for the program. But the simple fact is that consumers across the country will pay higher prices to cover the cost of the Alameda program.
And very few people are expected to actually participate. Vancouver, B.C.'s take-back program is often cited as a model, but a decade after its launch in 1997, a survey found that only 21 percent of respondents had made use of the program -- hardly justifying the cost and new bureaucracy.
Well-publicized, one-time take-back programs like the one in late April are a good way to raise awareness and encourage people to go through their medicine cabinets and dispose of unwanted pills. But the best "next step" is to educate consumers about proper and safe household disposal. There's no justification for the kind of permanent and mandatory take-back program that Alameda County is proposing.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.
U.S. District Judge Edward Korman, asked by the government on Tuesday to freeze his plan giving teenage girls broader access to morning-after birth control, instead seized the chance to accuse health officials of taking steps that would end up hurting poor people and improve their chances of prevailing in a protracted legal fight with reproductive rights advocates.
At a hearing in federal court in Brooklyn, Korman told an assistant U.S. attorney that the FDA ruling was a cynical attempt to "sugarcoat this appeal of yours."
Korman said he would issue a ruling before the end of the week on the request to stay his order. But he left little doubt about where he stood, accusing the Justice Department lawyer of "intellectual dishonesty" and calling further delays in the 12-year-old case "a charade."
"The poor, the young and African-Americans are going to be put in the position of not having access to this drug," he said. Making the same point earlier, he asked, "Is that the policy of the Obama administration?"Read More & Comment...
A new set of articles in Health Affairs about the declining rate of health care spending increases debate whether it's the recession or a slow down in the use of new technology. The authors conclude "that a host of fundamental changes—including less rapid development of imaging technology and new pharmaceuticals, increased patient cost sharing, and greater provider efficiency—were responsible for the majority of the slowdown in spending growth."
It is just the opposite.
The continuing decline since 2000 is the result of people living longer healthier lives due in large part to new devices and medicines for previously untreatable diseases. In particular, the decline in the spending rates correlates strongly with steep declines in morbidity and mortality from cancer. If you reduce the amount of people dying and being treated from a leading cause of death and illness you are going to slow the climb in health care spending.
Consider the following:
- Over the past 20 years, cancer deaths in the United States have dropped 30 percent, faster than in any time in history.
- The percentage of cancer patients who have to be hospitalized has been cut in half. The number of cancer survivors has more than doubled from about 6.8 million to 14 million today.
- That translates into 43 million additional life years worth $4.2 trillion in income.
Finally, as Frank Lichtenberg's recently updated paper on the contribution of new cancer therapies to longer life and greater value notes that "the cost of new cancer drugs is less than 1% of the value of the mortality reduction they yielded."
We need to reboot the way we pay for health care to capitalize on and encourage even more innovation. That, not a slowdown in the adoption of such technologies, will continue to make health care more affordable.
Discuss. Read More & Comment...
From the pages of the Tulsa World …
Commonsense cut to health care
By PETER PITTS
As Congress looks to slash federal spending, it ought to closely examine two health care initiatives run by alphabet-soup government bodies - one from the Agency for Health care Research and Quality (AHRQ), the other from the Patient-Centered Outcomes Research Institute (PCORI).
Over the past several years, these agencies' so-called "academic detailing" programs have spent tens of millions of dollars convincing doctors to change the way they write prescriptions. Unfortunately, these programs neglect patient health in favor of cost savings that in the long run may not amount to much of anything.
Who is the target?
"Detailing" is the practice of visiting health-care professionals to share information on the drugs they prescribe. The government's "academic detailing" is not done by actual academics, however. Rather, the agencies give an assortment of doctors, nurses, and pharmacists a set of government talking points and send them to meet with physicians and health-care professionals. Physicians are enticed into participating with the promise of continuing medical education credits, which they need to maintain their licenses and would normally pursue at their own expense.
The sessions often address drugs for diseases like diabetes, hypertension, dementia, and osteoporosis. The AHRQ now plans to expand its sessions to include guidelines on services such as mammograms and prostate screening. Each session concludes with specific recommendations regarding the doctor's prescribing habits.
Academic detailing might sound like a basic refresher course. But the government's contractors aren't reaching out to all doctors, or even focusing on those who need to improve patient care. Rather, they're targeting doctors who prescribe drugs often - even if those drugs work well, improve health, and save money over time by making hospitalization less likely.
The Department of Health and Human Services says the AHRQ program aims to promote "the cost-effective use of drugs," as opposed to practices that maximize health.
In addition, the detailers' recommendations are derived from research by PCORI and yet another government entity, the Preventive Services Task Force. This research is problematic for two reasons.
Dealing with humans
First, these studies are typically based on large-scale data sets rather than patient-by-patient analysis. The human body is complicated, and drugs that work for many patients may not work for all patients. Doctors often confront complex trade-offs - between effectiveness, interactions with other drugs, side effects, and price - that vary from patient to patient. And yet the government is advising physicians based on studies that ignore individual differences.
Second, just because this research bears the stamp of the federal government does not mean the findings are gospel and should be pushed on all doctors. Experts often disagree on important medical topics. For example, the Preventive Services Task Force recently recommended eliminating routine mammograms for women under 50. The American Cancer Society, on the other hand, continues to encourage mammograms starting at age 40.
In theory, it's possible that the detailers are presenting the research in a nuanced way - making clear that there is still a large role for physician discretion. But it's hard to know, thanks to a total lack of transparency.
As two former American Medical Association presidents noted in a recent letter, the AHRQ has failed to establish basic standards for disclosing how government money is being spent. The American people have no way of knowing how detailers are compensated, or even necessarily what they're supposed to achieve. The head of Total Therapeutic Management, a private firm contracted to conduct detailing for the AHRQ, says he measures success only by the remarkably unscientific standard of whether physicians say the sessions have been helpful.
Moreover, the agency refuses to divulge which doctors are receiving visits from detailers and what they're being told - hiding behind privacy regulations designed to protect patients, despite no patients being present during these sessions.
Government detailing is also unhindered by the standard restrictions that apply when pharmaceutical representatives visit doctors - even though the government is also trying to influence doctors' prescribing habits for financial gain. For example, pharmaceutical representatives can't encourage "off-label" drug uses, and their promotional materials must be vetted by the FDA; neither of these rules applies to government detailing. And of course, pharmaceutical reps can't pay doctors to listen with continuing medical education credits.
It's time to end academic detailing. Physicians should prescribe the medicines they judge most effective, not the ones the government thinks will save money.
In a speech at the annual meeting of the National Academy of Sciences, President Obama said that scientific research mustn’t ‘fall victim to political maneuvers or agendas that in some ways would impact on the integrity of the scientific process."
Except, of course, when such interference forwards his agenda.
‘Nuff said.Read More & Comment...
There should be one rule for reimbursement: If a treatment is targeted and works best in a particularly patient, it should be used and paid for. Indeed, many new medicines actually save health plans and hospitals money, especially if they target a particular mutation or disease mechanism in a smaller group of patients. Why should we pay more money for medicines that are more effective and more valuable? We shouldn't. And it speaks to the issue of patients being exposed to higher copays for cancer treatments that, while expensive, a less costly than the types of care they replace. So does The Cancer Drug Coverage Parity Act, H.R. 1801 a new congressional proposal to end discrimination against patients who opt for an oral form of therapy that works best for them. Sponsored by Congressman Brian Higgins (D-NY) the legislation would require insurance companies to cover patient-administered and physician-administered anticancer drugs at the same cost to patients.
This is a piece of legislation that ensures regulation keeps up with medical innovation. Let's hope it passes and is signed into law as quickly as possible.
Read More & Comment...
A new op-ed appearing in The Washington Times. Please excuse the headline – I didn’t write that. I support quality, legal generic medicines. I do not support the blatant disregard of intellectual property – or the dangerous and deleterious consequences such behavior has on the public heath.
When generics win, patients lose
Failure to protect patents stifles drug profits and innovation
A court ruling in India could stifle medical innovation worldwide.
On April 1, the Indian Supreme Court rejected a patent request for a version of the cancer treatment Gleevec, citing a 2005 law intended to thwart companies from obtaining fresh patents for minor changes to a medicine. The law itself, and the court’s decision, is a boon to India’s prosperous $26 billion generic-drug industry. The blatant failure to protect the intellectual property of biopharmaceutical innovators, though, will have terrible consequences for drug development and patient health.
Bringing a medicine to market is a long and complicated process. According to the Tufts Center for the Study of Drug Development, it takes 10 to 15 years for an experimental drug to reach the market. Including the costs of failures, each medicine costs an average $1.2 billion to develop.
Generic-drug manufacturers don’t have these massive upfront development costs. They don’t need to worry about investing in research and development for revenue. They piggyback on the research and investments of the pharmaceutical companies that create the brand names. India’s generic-drug manufacturers are among the largest in the world.
Gleevec, a cancer treatment from Swiss-based pharmaceutical company Novartis, was a major pharmaceutical breakthrough for cancer patients around the world. A patient advocacy group in Mumbai lauds it as “the only lifesaving drug” for chronic myeloid leukemia.
Gleevec is patented in nearly 40 countries, including China and Russia. Because the drug was introduced in India before the country enacted its first patent law in 2005, the treatment has gone unpatented.
When Novartis applied for a patent on a beta crystal reformulation of Gleevec, an important improvement that makes the medicine more stable, Indian regulators denied it, saying the difference between the two versions was too small. Novartis filed a petition with the Indian Supreme Court in 2009 to challenge the denial.
Novartis went to court not only to defend its patent interests for Gleevec, but also to defend the larger principle that intellectual-property protections are essential to innovation and the advances of medical science. The Indian Supreme Court’s decision essentially tells innovators not to bother improving on their products because they will reap no reward for doing so.
Some are trumpeting the case as a victory for patient access. The generic version of Gleevec costs about $175 per month per patient, compared with $2,600 for the brand-name drug.
The raw price comparison misses the point. Ninety-five percent of the 16,000 Indian patients prescribed Gleevec receive the medication at no charge through a program Novartis has established to ensure that poor, uninsured patients get the medications they need regardless of ability to pay. The other 5 percent are reimbursed or insured or are enrolled in a generous co-pay program.
Novartis has provided $1.7 billion worth of Gleevec to Indian cancer patients since 2002 and donated $2 billion worth of medicines to more than 100 million patients worldwide in 2012 alone.
Price isn’t the problem, and patents don’t prevent access in developing countries. In fact, few of the approximately 400 drugs on the World Health Organization’s model essential drug list have ever been patented in the world’s poorest countries.
Patent protection does foster continued progress. Sometimes progress comes in the form of a big breakthrough, but sometimes it’s just a matter of an incremental advance. Either way, the work behind new medicines should be protected.
The Indian Supreme Court’s ruling is a blow to global public health. India’s generic-drug industry will profit, but patients will suffer the consequences.
Peter J. Pitts, a former Food and Drug Administration associate commissioner, is president of the Center for Medicine in the Public Interest.Read More & Comment...
It is with mixed emotions that I write to inform you of the upcoming departure of Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy (GO), after 18 years of dedicated federal government service, including 11 years spent here at FDA.
Deb has overseen various critical programs within the Agency including, most recently, the GO Directorate. In that role, Deb has led the implementation of FDA’s strategy for addressing the challenges of globalization and import safety, including the paradigm shift that FDA must make to meet the challenges of globalization today and in the future through global coalitions, global data systems, advanced risk analytics, and leveraging of the efforts of public and private third parties. Deb has outlined a strong vision for GO that focuses on being data-driven, strategic, and risk-based, moving towards a stronger global product safety net to advance and protect public health. Prior to assuming the role of Deputy Commissioner, Deb worked in several critical positions within the Office of Compliance in FDA’s Center for Drug Evaluation and Research (CDER), including for five years as its Director.
Deb is leaving the Agency to take the position of Senior Vice President, Strategic Global Quality and Regulatory Policy at Mylan, Inc. Please join me in wishing Deb all the best as she and her family relocate to the Pittsburgh area and embark on this new endeavor. While I am sad to see Deb go, I am happy that she has found this terrific opportunity. Deb has demonstrated great leadership, creativity, and passion for public health throughout her FDA career, and we will miss her. Deb’s last day at FDA will be June 1, 2013.
I am pleased to announce that John M. Taylor, III, currently the Counselor to the Commissioner, has graciously agreed to serve as Acting Deputy Commissioner for Global Regulatory Operations and Policy in the short term starting May 18 as we look for a permanent replacement for Deb.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Read More & Comment...
In recent weeks, there have been increasing expressions of concern from surprising quarters about the implementation of ObamaCare. Montana Sen. Max Baucus, a Democrat, called it a "train wreck." A Democratic colleague, West Virginia's Sen. Jay Rockefeller, described the massive Affordable Care Act as "beyond comprehension." Henry Chao, the government's chief technical officer in charge of putting in place the insurance exchanges mandated by the law, was quoted in the Congressional Quarterly as saying "I'm pretty nervous . . . Let's just make sure it's not a third-world experience."
These individuals are worried for good reason. The unpopular health-care law's rollout is going to be rough. It will also administer several price (and other) shocks to tens of millions of Americans.
Read the full piece here.
Read More & Comment...
According to incoming PhRMA Chairman Robert Hugin (chairman and CEO of Celgene), the advocacy group’s agenda in the coming year will target policies that “most directly affect innovation and patient access to medicines.”
Starting with Medicare, PhRMA will focus the conversation on why policies that seek to control costs by targeting drug spending will hurt patients. Hugin: “We have to have a good defense; we have to play this part of the game.”
In short, it falls to PhRMA to lead the fight for “sustainable innovation.”
Hugin highlights two main areas of concern related to Medicare. First, he said. “We have to protect Medicare Part D. It is the role model for market-based solutions.” Next he pointed to an increasing concern in industry with retaining adequate reimbursement for drugs provided under Medicare Part B (generall administered by physicians). The growth in very high-priced specialty drugs, such as targeted cancer therapies, is contributing to a new focus among payers on containing Part B drug costs.
Hugin: “We have to defend Part B. We have to ensure that reimbursement rates don’t change so significantly that access to patients for those types of medicines, physician-administered, are restricted, and [that] leads patients back to hospitals and higher [overall medical] costs.”
Among the other advocacy priorities, Hugin points to the need to “ensure the 340B program is administered effectively and appropriately.”
According to Hugin, PhRMA will also focus on making sure the 12-year marketing exclusivity available to biologics under the law for biosimilars “is maintained, not just in this country, but in all the trade agreements that our country negotiates.” He also said that industry must “assertively defend intellectual property all across the globe.”
As per state exchanges and other codicils of the Affordable Care Act, Hugin stressed that, “We have to make sure that we support initiatives that … do not restrict access to important innovative medicines for patients all across this country.” And he vowed to “continue the fight” to repeal the Independent Payment Advisory Board, which was established by the ACA.
The biopharmaceutical industry, per Chairman Bob, must continue to support FDA and ensure “proper funding” of drug review programs “so that we have a 21st century regulatory science system that allows us, in the most cost-effective and rapid way, to bring new therapies to patients.” He commented that the trade association’s experience in negotiating the most recent prescription drug user fee act reauthorization bill, which was enacted last year with bipartisan support, was a “remarkably” positive one.
Nobody said it was going to be easy.
When it comes to biologics, "the product is the process." Since the finished product cannot be fully characterized in the laboratory, manufacturers must ensure product consistency, quality, and purity by ensuring that the manufacturing process remains substantially the same over time.
As we move (albeit cautiously) into the era of biosimilars, one of the hoped-for advances is in manufacturing. Saying that such technologies are complicated is an understatement.
To achieve real success towards “better, faster, cheaper,” it is in the best interests of the public health for process mavens to work closely with the FDA to determine how new technologies can be expeditiously incorporated into biologics manufacturing standards.
Perhaps its time for the time for the FDA to create an advisory committee on biologics manufacturing standards and practices.Read More & Comment...
From today’s edition of the South Florida Sun Sentinel
Low costs medicines could jeopardize patient health
In Florida's House and Senate, lawmakers are currently working on legislation that would enable patients to purchase lower-cost alternatives to some of today's most-advanced medicines.
Unfortunately, a recent amendment to the legislation undermines the physican-patient relationship. It's critical for lawmakers to revert to their original proposal.
The legislation under consideration deals with a new class of medicines known as "biologics."
Unlike conventional drugs, which are made using basic chemical reactions, biologics are actually grown using living organisms. So they're much more complex. Consequently, when the patent on a biologic expires, competitors aren't able to make exact copies. But they can come close — so imitation biologics are called "biosimilars" instead of "generics."
Under federal law, the Food and Drug Administration will soon begin approving biosimilars. But the agency doesn't plan to issue any product-specific guidance to physicians or pharmacists prior to approving these drugs. And, it's not within the FDA's jurisdiction to tell states how to address the substitution of interchangeable biosimilars at the pharmacy — that responsibility falls to the state.
When Florida lawmakers in both chambers started work on their bills, they were model pieces of legislation — striking a balance between ensuring patient safety, and creating open access for more affordable new treatments.
The original bills stipulated Florida pharmacists would only be allowed to substitute a biosimilar for its brand counterpart if the FDA had certified the medicine as interchangeable with the innovator biologic.
The human body is complicated, of course, so it's possible that some biosimilars — even those deemed interchangeable by the FDA — will not work properly for certain patients, and because of the interaction of these treatments with a patient's immune system serious consequences can result.
The original legislation also required pharmacists to notify patients if a substitution had been made. And, because adverse reactions may not manifest themselves immediately, the bill also asked pharmacists to maintain dispensing records for four years. In the event that a biologic or biosimilar does not provide the intended treatment outcome, such records will prove vital.
Finally, and most importantly, the bill required pharmacists to notify prescribing physicians within ten days if a substitution had been made. It's important to underscore that this notification is required after the patient has already received the biosimilar.
These are all commonsense ssafeguards. They ensure that patients can access these less expensive new modifications safely.
But over the past week, House and Senate lawmakers have stripped the physician notification from their bill. This doesn't make sense — it ignores the most fundamental aspect of protecting the patient by cutting doctors out of the loop.
This change undermines patient safety. Biologics are incredibly complex — on average, they contain 1,000 times the number of atoms found in conventional chemical drugs. Doctors, especially those treating patients with multiple chronic or autoimmune conditions, need to know when their patients walk away from the pharmacy counter with a different medicine than the one they prescribed.
This change also undercuts physician autonomy and ignores the importance of transparency. In order to effectively treat their patients and protect against unintended health effects, doctors have the right to know if a substitution is made.
In both the House and the Senate, the earlier draft of the bill puts patients first. As lawmakers finalize this measure, it's critical that they fulfill their responsibility to keep patients at the cent of this debate, and to make sure that the legislation passes with all protections intact.
Peter J. Pitts, a former FDA Associate Commissioner, is the president of the Center for Medicine in the Public Interest.
Read More & Comment...
FDA Cautions in Interpretation of Antimicrobial Resistance Data
Recently, the Environmental Working Group issued a report of its interpretation of the 2011 Retail Meat Annual Report of the National Antimicrobial Resistance Monitoring System (NARMS). While FDA is always concerned when we see antimicrobial resistance, we believe the EWG report oversimplifies the NARMS data and provides misleading conclusions. We do not believe that EWG fully considered important factors that put these results in context, including:
- whether the bacterium is a foodborne pathogen. The report highlights resistance to Enterococcus, but this is not considered a foodborne pathogen. Instead, we include it because its behavior is helpful in understanding how resistance occurs.
- which drug(s) the bacterium is naturally resistant to. For example, most Enterococcus faecalis is naturally resistant to the antibiotic class of lincosamides. Because we know and expect to see this resistance, we are not as concerned with resistance in this species the way we would be with resistance in true pathogens like Salmonella and Campylobacter.
- why NARMS includes certain drugs in its testing design. We include some antibiotics for epidemiology purposes-- to track the spread of certain bacteria or certain genes. But resistance to these antibiotics doesn’t reflect a danger to public health.
- whether the antibiotics that are commonly used to treat patients are still effective. NARMS data indicates that first-line treatments for all four bacteria that we track (Salmonella, Enterococcus, Escherichia coli and Campylobacter) are still effective.
- what the 2011 data indicate relative to similar data reported for prior years.
Additionally, we believe that it is inaccurate and alarmist to define bacteria resistant to one, or even a few, antimicrobials as “superbugs” if these same bacteria are still treatable by other commonly used antibiotics. This is especially misleading when speaking of bacteria that do not cause foodborne disease and have natural resistances, such as Enterococcus.
When taking such factors into account, FDA believes the notable findings in the 2011 NARMS Report include:
- In the critically important class of antimicrobials, the 2011 data showed no fluoroquinolone resistance in Salmonella from any source. This is the drug of choice for treating adults with Salmonella.
- Trimethoprim-sulfonamide is another drug used to treat Salmonella infections and resistance remains low (0% to 3.7%).
- Fluoroquinolone resistance in Campylobacter has stopped increasing and remained essentially unchanged since the FDA withdrew the use of this drug class in poultry in 2005.
- Macrolide antibiotic resistance in retail chicken isolates remains low, with 2011 results at 0.5% of Campylobacter jejuni and 4.3% of Campylobacter coli. The macrolide antibiotic erythromycin is the drug of choice for treating Campylobacter infections.
- Multidrug resistance is rare in Campylobacter. Only nine out of 634 Campylobacter isolates from poultry were resistant to 3 or more antimicrobial classes in 2011. However, gentamicin resistance in Campylobacter coli markedly increased from 0.7% in 2007 (when it first appeared in the NARMS retail meat report) to 18.1% in 2011. Gentamicin has been suggested as a possible second-line therapy for Campylobacter infections, although it is not commonly used.
- Resistance to third-generation cephalosporins, which are used to treat salmonellosis, has increased in Salmonella from chicken (10 to 33.5%) and turkey (8.1 to 22.4%) meats when comparing 2002 and 2011 percentages. FDA noted this development in previous years and has already taken action by prohibiting certain extra-label uses of cephalosporins in cows, pigs, chickens and turkeys, and is continuing to closely monitor resistance to these drugs.
Antimicrobial resistance is a serious and challenging issue. It is critically important that we continue our efforts to minimize antimicrobial resistance, including promoting appropriate and judicious use of antimicrobials in both humans and animals.Based on a thorough review of the available scientific information, FDA has created a strategy for the judicious use of medically important antimicrobials in food-producing animals that states their use should be limited to situations where the drugs are necessary for ensuring animal health, and done so under veterinary guidance. It is the non-judicious use – for growth promotion and feed efficiency – that is of particular concern to FDA. This collaborative strategy is intended to provide the quickest way to achieve the greatest degree of public health protection, but it does not prevent FDA from initiating regulatory action in the future, if the agency finds it necessary. FDA welcomes all contributions in helping to understand and address the challenge of antibiotic resistance. However, it is very important to look at the NARMS data in the proper context, with a good understanding of the microbiology, epidemiology and genetics of antibiotic-resistant foodborne pathogens and their clinical management. Read More & Comment...