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Nature reports:
FDA under pressure to relax drug rules
Industry says antibiotic pipeline is being blocked by overly stringent clinical-trial requirements for new treatments.
The latest skirmish in the battle between human and microbe played out on 29 November in a hotel conference room in Silver Spring, Maryland. There, an assembly of scientists and clinicians debated the merits of an experimental antibiotic. For some, the coveted prize was not just an endorsement of the drug itself, but a sign that the US Food and Drug Administration (FDA) is finally ready to rethink its clinical-trial requirements for antibiotics — requirements that the drug industry says are unrealistic.
The number of FDA approvals of new antibiotics has dropped even as multi-drug-resistant strains of bacteria have proliferated. FDA advisers at last week’s meeting did recommend approval of telavancin (Vibativ) — a derivative of vancomycin — for the treatment of hospital-acquired pneumonia when alternative drugs are not suitable. But that vote came nearly two years after the FDA had rejected the drug for a second time because clinical data did not measure up to the agency’s guidelines.
“The agency has painted itself into a statistical corner,” says Scott Hopkins, chief medical officer of Rib-X, a drug company in New Haven, Connecticut, focused on antibiotics. “While the infectious-disease community was crying out for new antibiotics, the FDA seemed to be going in the opposite direction.”
Many trace the agency’s tougher stance to the scandal surrounding telithromycin (Ketek), an antibiotic approved by the FDA in 2004 and later linked to liver failure. In 2007, the US Congress launched an investigation into whether the FDA had ignored staff concerns about Ketek’s safety. The following year, the agency convened its advisers to discuss antibiotics then under review. “Four drugs representing over a billion dollars of investment went into that week and only one came out alive,” recalls Mark Leuchtenberger, president of Rib-X.
Telavancin was caught in the changing tides. When Theravance, the company in South San Francisco, California, that developed the drug, designed the large phase III clinical trials needed for approval, the FDA simply required a demonstration that the drug eliminated symptoms of infection as reliably as the approved antibiotic vancomycin. But, after Theravance submitted its second application on 30 June 2010, the FDA decided instead that applicants needed to show that patients were no more likely to die — of any cause — within 28 days of treatment with a new drug.
Theravance scrambled to gather the data, hunting down medical records for 1,419 out of the 1,503 patients scattered across dozens of countries that were enrolled in the telavancin trials. But the FDA determined that the study lacked statistical power and asked for new clinical studies. Theravance refused, and a stalemate followed.
Strict clinical guidelines for antibiotics have dogged the industry ever since, with pneumonia providing a good illustration. Patients who contract pneumonia in hospital are already ill, making it hard to know if the treatment under review played a part in their death. That means trials have to be larger to capture enough deaths to have any statistical meaning. This, combined with the relative rarity of infections that warrant the use of new antibiotics and the further FDA requirement that patients not receive other antibiotics before they get the experimental drug, has set the goal out of reach, argues David Shlaes, who runs Anti-Infectives Consulting in Stonington, Connecticut. Not a single new antibiotic for hospital-acquired pneumonia has been submitted for approval since the new guidelines were put in place. “The trial simply cannot be done,” says Shlaes. “Whoever was writing these guidance documents doesn’t live on the same planet that I do.”
However, since the Ketek scandal, the political winds have reversed. This summer, Congress passed a set of measures to encourage antibiotic development. In May, Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, pledged to “reboot” the antibiotic-approval process. And in September, the FDA told Theravance that its advisers would take another look at telavancin, resulting in last week’s vote.
Investors have also noticed these changes, says Leuchtenberger. Last week, Rib-X announced that it had raised US$18.7 million to help the company start phase III trials of an antibiotic that could target skin infections. “Without some of these positive developments this year, you’re looking at a number of companies that might not be around any more,” he says.
Shlaes, however, emerged from the telavancin meeting still doubtful, noting a continued focus on all-cause mortality. He says that, for now, he will continue to advise his clients to apply for approval in Europe first, where regulators have not been as demanding as the FDA. “I’ve been very optimistic about the whole thing,” he says. “But the FDA has to do something to show that it is actually rebooting.”
Read More & Comment...I was pleased to chair the Fifth Annual Risk Management and Drug Safety Summit.
REMS is a tactic. Safe Use is a strategy and Safe Use is the new normal.
Some take-aways:
According to Greg Fiore, MD (Chief Medical Officer and Acting Head of Global Pharmacovigilance at The Medicines Company), we are now in a “new world order” where pharmacovigilance teams finally have a seat at the table. But, per Fiore, we are still spending too much time, talent, and treasure of process – and not nearly enough on insights development and use.
Good points. Could this be because ever-more process is a good excuse for actually doing something? Such action would require not just more dollars and FTEs for PV teams – but would also mean changing the cognitive mapping of the way many companies do business. It might actually mean that patient safety takes priority over marketing and sales.
Fiore also mentioned the need to consider what benefits a more aggressive use of social media might mean for pharmacovigilance.
Is it time to “friend” Gerald Del Pan?
Josephine Torrente, JD (a Director at Hyman, Phelps & McNamara), made the point that REMS is labeling (a view held by most at the conference) and that the implications for shared REMS must be taken into account – especially when it comes to biosimilars. Josephine also addressed the issue of possible FDA waivers from shared REMS programs. She doesn’t see it as likely.
Is this another possible point of political intrusion? As with Plan B, will the HHS Secretary decide to grant such a waiver if the FDA declines to do so? Ms. Torrente feels petitioning the Humphrey Building for such divine intervention would have little chance of success. Glad to hear that.
The class-wide Opioid REMS was much on everyone’s mind, and Stuart Kim, JD (Senior Regulatory Counsel, Covidien), made a strong case for a more active role by state-level stakeholders. The context for this was the crucial need to differentiate the desire to address abuse versus misuse. The failure to recognize the different nature of these issues will lead to negative and unintended consequences. He also asked, per the CME requirements, why we are not looking to a more thoughtful level of measurement. Just “ticking the box” on CME won’t solve any problems. Rather, Stuart pointed to a goal of a Moore’s Scale Level 7 achievement of actually improving patient outcomes.
For more on Moore’s Scale, see here.
Addressing abuse is one thing – but smartly dealing with misuse (while not as sexy or politically potent) is at least of equal import.
After Stuart’s presentation, I offered the following prediction:
FDA will not approve generic opioids minus the innovator-developed abuse-resistant technologies – unless they are forced to. IP issues? You bet. Watch this space for more on this issue as it rises to the top of the FDA agenda. (And don’t be thrown off-guard by what’s going on north of the border.)
Eleanor Segal, MD (Consultant, Segal PV Systems), discussed pharmacovigilance trends in the EU, with specific focus on how the EU is actually becomes less harmonized both between it’s own members – and with the FDA. And the new EU directive on Phase IV studies didn’t give anyone a warm and fuzzy feeling.
James Frame, MD (Medical Director, David Lee Cancer Center, Chair of ASCO REMS Working Group, and President, West Virginia Oncology Society) spoke about the “onerous” burdens that many REMS plans are placing on physicians. Not news, but he made the good point that such burdens impact patient access issues such as time spent with physician, availability of support staff to address patient needs – both of which could actually lead to less optimal care. Unintended consequences – but certainly not unpredictable when both sponsor and agency fail to take the weight of “practice burden” into account.
It’s the risk of risk mitigation.
Maybe its time for the FDA (and sponsors) to engage a “physician representative” when it comes to REMS design.
Day One ended with a thoughtful presentation by former FDAer Lynn Mehler, JD (Partner, Hogan Lovells). Lynn predicted that the FDA would be looking forward to more class-wide REMS.
We shall see.
Richard Hermann, MD (Safety Science Physician, Patient Safety, Global Regulatory Affairs, AstraZeneca) brought the issue of risk/benefit analysis via a validated grid into the conversation. His baby, the BRAT, is only one methodology under discussion – but it is an important one in the “date versus information” debate. He urged the audience not be prisoners of process and to fight cultures that are resistant to change be they in industry or at the FDA. He acknowledged that many firms are operating in a “change-weary environment.”
Well, if the Pope can start tweeting and off-label promotion is protected free speech, there is hope for us all.
What will tomorrow bring.
Read More & Comment...Fasten your seatbelts.
Court: off-label promotion protected
The U.S. Court of Appeals for the Second Circuit said in a 2-1 ruling in United States v. Caronia on Monday that the "government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetic Act (FDCA)] for speech promoting the lawful, off-label use of an FDA-approved drug." In the ruling, Judge Denny Chin wrote that so long as the off-label use of the FDA-approved drug is legal, the government's interpretation of FDCA's misbranding provisions to prohibit and criminalize the promotion of off-label use "unconstitutionally restrict[s] speech." FDCA prohibits misbranding, but does not expressly prohibit the promotion or marketing of drugs for off-label use. Chin noted that off-label promotion that is false or misleading is not protected by the First Amendment. In a dissenting opinion,
Judge Debra Ann Livingston said the ruling "calls into question the very foundations of our century-old system of drug regulation," adding that if drug companies "were allowed to promote FDA-approved drugs for nonapproved uses, they would have little incentive to seek FDA approval for those uses."
The case concerns Alfred Caronia, a former specialty sales consultant at Orphan Medical, which was acquired by Jazz Pharmaceuticals plc. He was convicted in 2008 of conspiracy to introduce a misbranded drug into interstate commerce based on audio recordings in which he promoted the off-label use of narcolepsy drug Xyrem sodium oxybate. Caronia, who was sentenced to one-year probation and 100 hours of community service, appealed, arguing that his conviction was based solely on his speech and therefore violated his First Amendment rights.
The appeals court vacated and remanded to the lower court the decision convicting Caronia.
So I did some rough calculations: According to CMS the percent increase in Rx filled per year in Part D from 2007 -2009 was 5.6 percent. That lead to an increase in part D spending of about 5.7 billion. Assuming a 5.6 percent decline in the rate of medicare spending I come up with a savings of $30 billion. (The additional spending that would have occured in the absence of drug utilization.) That means every dollar spent on Part D saves about $6 in Medicare spending. Lichtenberg estimates $1 dollar of drug spending on new drugs saves $7. This is a bit below his estimate (few new drugs were introduced since 2006) but now CBO has essentially "blessed" the offset
Read More & Comment...
According to “Pay it Forward,” Medical Marketing & Media’s overview of 2013 …
After a tumultuous few years of healthcare policymaking, the recent election brought a big victory for Obamacare. It's now all systems go for the law, with sweeping change for the American healthcare system and tens of millions more insured. Expect this status quo to be anything but boring.
ACA implementation isn't the most immediate cause for anxiety among healthcare policy types. That honor goes to the “sequester,” a high-stakes game of budgetary chicken set to play out over the next month or so. Last year's standoff between the White House and Congressional Republicans over the “debt ceiling” was resolved, in classic Washington fashion, by kicking the can down the road a bit, but with a twist—if the two sides couldn't agree on painful cost savings by January 2, a legislative “trigger” would be tripped prompting brutally deep cuts (of $1.2 trillion over nine years) to defense and social spending. Medicare is largely exempt from the cuts—limited to 2% of its budget—and Medicaid and CHIP are off-limits. FDA, however, would face deep cuts—projected at $318 million—that would slow approvals and rules-making, according to the Office of Management and Budget, and effectively freeze PDUFA.
“Sequestration would be a complete disaster for all involved,” says Peter Pitts, former FDA associate commissioner. “The FDA simply doesn't have any slack in its budget and would not have the bodies to do things on time. This is not the status quo but a significant step backwards.”
The rest of the article can be found here.
Read More & Comment...NEW YORK (AP) — Rose Wang looks at her staff of 70 employees and wonders if she'll have to lay off some of them to comply with the health care law.
The owner of Binary Group Inc., an information technology firm based in Alexandria, Va., is one of many small business owners who will be required to provide health insurance for her staffers under a provision of the law that goes into effect on Jan. 1, 2014. Wang already provides insurance, but she has struggled with premiums that have soared as much as 60 percent annually, so she requires employees to contribute to their coverage. She's worried because she doesn't know how much she'll have to pay under the Affordable Care Act.
Wang's worry is a gut-wrenching dilemma that many small business owners are concerned that they may face. Now that President Barack Obama has won re-election, the health care overhaul, which presidential candidate Mitt Romney promised to dismantle, is marching forward. Companies must decide before the start of 2014 what they'll do to comply with the law. Right now, no one knows how much the insurance will cost, and owners aren't sure if they'd be better off not buying it and paying a government a penalty of $2,000 per worker. Some owners are even threatening to defy the law. The big challenge for most small businesses is that they just don't have enough information to make concrete plans.
If Wang can't afford the insurance, she says that some of her staffers may have to go.
"I would have to say, 'look, guys, you're family to me in many respects, but this family also depends on having the kind of cash flow available to keep the lights on and keep employing most of you,'" Wang says. "It would have to come down to that."
Read the full piece here.
Read More & Comment...
Alas -- there's no accounting for taste.
From the pages of Medical Marketing & Media:
European regulators to publish clinical trials data
The head of the European Medicines Agency has said it's a matter of how, not if, the body will mandate publication of clinical trials data – and that has pharmas on both sides of the Atlantic sweating the potential implications for global competitiveness.
EMA executive director Guido Rasi said last week “The European Medicines Agency is committed to proactive publication of clinical trial data, once the marketing authorization process has ended. We are not here to decide if we publish clinical trial data, but how.”
His remarks came at the start of a daylong workshop in London on data transparency around clinical trials. The agency has convened several advisory groups, including some representation from industry, to grapple with thorny issues including patient confidentiality, data formats, rules of engagement, good analysis practice and legal aspects. They will start work in early 2013 and are expected to deliver their recommendations by the end of April, with mandatory publication of trials data taking effect on January 1, 2014.
“The implications are rather significant relative to the continued protection of intellectual property rights,” said Peter Pitts of the Center for Medicine in the Public Interest, “and continued incentives—or disincentives—to invest in innovation.”
The full article can be found here.
Read More & Comment...Gulf News
Experts stress need for innovation in healthcare
Regulation will ensure adequate supplies of medicinal stocks, says ministry
By Carolina D’Souza, Staff Reporter
November 28, 2012
Dubai: The UAE is intensifying its efforts to increase availability of medical technologies and drugs. This key message was delivered by the UAE Ministry of Health (MoH) during the opening of a two-day conference on Wednesday.
The Ministry believes that the UAE is one of the leading countries in the region to provide innovative medicine.
The conference titled ‘Competitiveness Forum: Health Care and Access to Innovative Medicines in the UAE’ brought together senior officials from the MoH, healthcare authorities, Ministry of Economy and GCC regulatory bodies as well as representatives from the private pharmaceutical sector.
Speaking to Gulf News, professor Peter Pitts, president of the Centre for Medicine in the Public Interest (CMPI), said, “The UAE has smartly figured out that by partnering with the pharmaceutical industry, it can bring innovation to the country and make it a hub of innovation.”
He said that the UAE is recognised for its speed in marketing new medicines and providing patients with the newest medical technologies. Stressing on the need for innovation in medicine, he explained that incremental innovation is more common — than one-time innovation — through which companies enhance a product or a technology.
Extending lives
“Stakeholders, governments and regulators should support innovation in healthcare — it extends peoples’ lives,” said Pitts.
Dr Amin Hussain Al Amiri, assistant undersecretary for Medical Practices and Licensing at the MoH, said that innovative medicines are key drivers for growth in the healthcare sector. “The UAE is one of the leading countries, providing its residents with all kinds of medicine, including life-saving drugs. Through regulations, we will ensure that new medicines are introduced and adequate stocks are maintained for all healthcare needs.”
Dr Ola Al Ahdab, pharmaceutical consultant for registration and drug control at the MoH, told Gulf News that access to timely and advanced medicine is a top priority for the UAE government.
Chair of the conference organising committee Dr. Yaqoub Haddad added, through this conference, the pharmaceutical companies and stakeholders will be able to identify strengths and weaknesses in the healthcare sectors to continue to provide access to innovative medicine.
Read More & Comment...At Barnes-Jewish Hospital, Dr. Lynch said physicians from all over the Midwest referred their sickest heart patients to his facility for transplants and other major interventions. But those patients can skew his hospital’s readmissions numbers, he said: “The weaker your heart, the more advanced your emphysema, the more likely you are to be readmitted to the hospital.”
Dr. Lynch said Barnes-Jewish set up follow-up appointments for patients who didn’t have their own doctors. But about half of the patients never showed up, he said, even after the hospital made reminder phone calls and arranged for free rides. Sending nurses to see patients at home did not significantly reduce readmission rates either, he said.
“Many of us have been working on this for other reasons than a penalty for many years, and we’ve found it’s very hard to move,” Dr. Lynch said. He said the penalties were unfair to hospitals with the double burden of caring for very sick and very poor patients.
“For us, it’s not a readmissions penalty,” he said. “It’s a mission penalty.”
Read the full New York Times piece here.
Read More & Comment...
The first step towards solving a problem is to identify that a problem exists.
The breakthrough therapy provision in FDASIA is aimed at shortening the development time for drugs intended to treat serious or life-threatening conditions and for which preliminary clinical evidence suggests a substantial improvement over existing therapies. But the devil is in the developmental details.
But the promise of speeding innovative medicines to market could be blunted unless issues related to manufacturing, companion diagnostics and international harmonization are adequately addressed.
That was the message from a multi-stakeholder panel discussion at the November 14th Conference on Clinical Cancer Research, co-sponsored by the Friends of Cancer Research and the Engelberg Center for Health Care Reform at Brookings.
Panelists and FDA representatives agreed that if a drug is ushered through the development process, hold-ups will arise from other areas. As a result, discussions surrounding chemistry, manufacturing and control issues for new drugs and biologics will need to take place much earlier in the clinical development process than currently happens to avoid a situation where a breakthrough therapy is approved but the manufacturing processes are not in place to support commercial marketing.
Discovery is one thing. Development and commercialization are another. Nobody said it was going to be easy.
Breakthrough treatments that require companion diagnostics also could be potentially problematic, as the development, validation and approval of the diagnostic may not be able to keep pace with the drug’s abbreviated clinical development program.
Under FDASIA, sponsors must request that their product be designated as a breakthrough therapy, and FDA must respond within 60 days. For drugs receiving the designation, the agency must work in a variety of ways to expedite the products’ development and review, including providing timely advice to the sponsor to ensure the development program is as efficient as possible and involving senior managers and experienced review staff in a collaborative cross-disciplinary review.
Under the law, FDA must issue draft guidance by January 2014 on the process and criteria for making designations and actions the agency will take to expedite development and review.
What about international harmonization? During the development of the FDASIA legislation, Woodcock cited the need for FDA and EMA to “be on the same page” about abbreviated development programs for breakthrough therapies. And, according to a conference issues brief, absent an equivalent development pathway in the EU, “drugs that receive breakthrough designation in the U.S. may still be required to go through the traditional drug development pathway for EMA approval. These differing requirements may make the breakthrough pathway an unattractive option for drug sponsors.’
Richard Pazdur raised the question as to what happens when subsequent studies of a breakthrough-designated product fail to confirm the encouraging efficacy signal seen early in development. Bob Temple suggested the agency’s guidance on breakthrough designations would account for such a scenario. “The concept clearly includes the possibility that it looked really good at first and then now it doesn’t and so it’s designation could go away,” he said. “I’m sure there will be a provision for that.”
That's one thing we can most certainly be sure of. Caveat emptor.
“PR” does not stand for “Post Regulatory” – nor should it.
Via an untitled letter concerning a pitch letter, the FDA sent out an important holiday reminder that press materials are, indeed, regulated speech.
The target of the October 31st letter was Cornerstone Therapeutics. Their press release for its Curosurf (indicated for rescue treatment of premature infants experiencing Respiratory Distress Syndrome) was, according to the FDA, false and misleading due to omission of risk info and presentation of unsubstantiated superiority claims. A pretty standard objection, and an obvious mistake that should have been avoided by the Cornerstone communications staff.
Communications departments and PR agencies beware – play by the rules or suffer the consequences.
The Problem of Fake and Useless Drugs
Global health authorities are making only fitful progress toward eliminating fake or substandard drugs that cause widespread suffering and death in the developing world. Delegates from 76 member countries of the World Health Organization met this week in Buenos Aires to lay the groundwork for more forceful action.
No one knows precisely how much fraudulent or substandard medicine is sold around the world, but the fragmentary data are alarming. In poor countries, half of the medicines used to treat some deadly diseases have been found to be fakes that had little or no active ingredient; worse yet, some contained toxic substances.
One estimate by experts is that at least 100,000 people die every year from substandard and fake medicines for cancer, heart disease, infectious diseases and other ailments. Fake malaria drugs pose a real risk of hampering the international effort to curb the disease. In wealthy nations, substandard or fraudulent drugs have caused thousands of adverse reactions and some deaths.
The United States, despite having a strong regulatory agency, is hardly immune to this problem. In recent years, fake doses of Avastin sold to physician groups for cancer treatment lacked the active ingredient; a weight-loss medicine contained undeclared ingredients that posed a health risk; and compounding pharmacies have produced contaminated drugs that caused meningitis and deaths.
An analysis by health experts published in the British Medical Journal last week lamented the lack of progress in addressing this scourge. The group called for a global treaty backed by governments, drug companies and nongovernmental groups to ensure a safe drug supply.
Crackdowns by international police and national regulatory agencies have made progress in shutting down dangerous online pharmacies. But, in poor countries, the greater problem is keeping bad products out of the supply chain that serves pharmacies and health care provider groups. In Kenya, even Doctors Without Borders, a smart operation, was duped into buying fake antiretroviral drugs to combat AIDS, which it gave to thousands of patients before the fraud was discovered.
There is an urgent need for a more vigorous international effort. That might include stronger surveillance and research to determine the extent of the problem, clearer definitions for bad drugs (substandard, counterfeit, falsely labeled, falsified or fraudulent drugs, for example) and new international laws to make it a crime to traffic in such medicines. Read More & Comment...HHS has issues a proposed rule that would increase the number of drugs eligible for reimbursement by insurers under the Affordable Care Act's essential health benefits requirements. In a previous bulletin, HHS said it planned to require that essential health benefits cover only one drug in each therapeutic class included in benchmark plans put forward by each state. The new rule essentially changes the language from 'only one' to 'at least one' drug, requiring that insurers cover at least one drug per therapeutic area or the same number of drugs in each category and class as specified in the state benchmark plan, whichever is greater.
BioCentury reports that the proposed rule also states that a plan "must have procedures in place that allow an enrollee to request clinically appropriate drugs not covered by the health plan." Comments on the proposed rule are due Dec. 26. Previous comments on HHS' bulletin said a one-drug requirement would have provided insufficient access to medications for some conditions. Medicare Part D requires that drug plans provide access to "all or substantially all" medications in six therapeutic classes.
HHS also released a proposed rule that prohibits health insurance companies from discriminating because of a preexisting or chronic condition, as well as a proposed rule on implementing and expanding employment-based wellness programs.
Read More & Comment...
When it comes to jurisdiction over compounding pharmacies, Senator Lamar Alexander (R, TN), wants someone “on the flag pole” responsible for ensuring that non-traditional compounders meet set federal standards.
Alexander proposed allowing FDA to designate state boards of pharmacy as the primary regulator, if they are willing and able. If the state regulators proved unable or made mistakes, FDA would have the ability to take over regulation.
FDA Commissioner Hamburg gave that idea a positive nod, saying it was one model that could be explored, but she still wants federal regulations to assure consistency.
“I think it should be made explicit,” she said. “I think for non-traditional compounding there should be federal standards that apply to certain types of practices that go to issues of quality and safety.”
FDA said those facilities should be required to submit to inspections, report adverse events and register with the agency.
On the House side, Tom Harkin (D, IA), suggested that compounding facilities shipping across state lines should come under FDA scrutiny. Other ideas included using a volume threshold and prescription records.
If the FDA gets more responsibility – which is looking increasingly likely -- they will also need more funding. Otherwise this is all just C-SPAN rhetoric.
Did somebody say “sequestration?”
Read More & Comment...The election may be over, but the malarkey continues.
The most recent Marlarkey Alert comes to us courtesy of the New York Times editorial page.
In defense of the IPAB, the Gray Lady editorializes:
The board, known as the Independent Payment Advisory Board, has been the subject of false attacks over the past few years by Republicans who claim that it will ration care, disrupt doctor-patient relationships, and tell patients what treatments they can receive. That is an outlandish way to describe a board that is prohibited by law from making any recommendations to ration care, raise premiums, increase cost-sharing, restrict benefits or limit eligibility.
That’s malarkey.
Medicare spending is expected to be $575.7 billion this year, jumping to over $1 trillion by 2022, as the country ages. Over the next 75 years, the program is projected to accumulate a $38 trillion budget shortfall.
Much of this enormous price tag goes towards financing Medicare Parts A (hospital insurance) and B (medical services -- including diagnostic tests and doctor visits). And yet, IPAB has no authority over either. And the board can’t make any substantive structural changes. Neither the fee-for-service structure nor enrollee premiums and fees can be altered.
The board’s only viable option is to further ratchet down reimbursement rates for Medicare providers, especially doctors, who are already losing money on Medicare patients. Indeed, the financial burden of too-low payments under Medicare has driven 17 percent of doctors and 31 percent of primary care physicians across the country out of the Medicare program altogether, according to a study from the American Medical Association.
If rates fall any lower, seniors will have an increasingly difficult time securing doctor appointments. Visits will be cut short to squeeze in patients and care compromised.
Lawmakers must cast aside IPAB’s flawed approach (and the media malarkey surrounding it) and focus instead on innovative initiatives that address the program’s real cost-drivers while protecting seniors’ access to care.
Read More & Comment...There is no greater disaster than greed.
– Lao-tzu
The tragic deaths caused by the current drug compounding scandal could so easily have been avoided. The root cause wasn’t a drug shortage – it was greed.
A new effort by Representatives Ed Markey (D, MA), Henry Waxman (D, CA), John Dingell (D, MI), Frank Pallone, Jr. (D, NJ), Diana DeGette (D, CO), and Anna Eschoo (D, CA) is aimed at getting to the bottom of the problem by investigating the roles of the players in this horrible drama – specifically the actions of Group Purchasing Organizations (GPOs).
Mr. Markey: “As Congress fully investigates all the causes of the tragic meningitis outbreak in an effort to protect patients in the future, we need to look at the role GPOs play in the occurrence of drug shortages that could lead to increased reliance on compounding pharmacies.”
“Through our investigation into drug shortages and the meningitis outbreak, we have discovered that medical professionals have increasingly been turning to compounding pharmacies for their prescription needs,” said Mr. Dingell. “It is important we study every potential cause of this outbreak in order to get to the bottom of this health crisis. I look forward to working with my colleagues in the coming weeks to explore legislative approaches that will address this matter.”
Representative DeGette: “While we've begun to address drug shortages legislatively, it is clear we must aggressively investigate the factors that led to this deadly outbreak and determine possible remedies, so we can take steps to save patients lives.”
“If group purchasing organizations are taking advantage of their unique role in facilitating a safe and reliable drug supply, then we need to know about it,” said Representative Eshoo.
Mr. Waxman, “In light of the tragedy of the meningitis outbreak linked to contaminated compounded drugs, we need to look carefully at all factors that might be contributing to the increasing use of compounded drugs by hospitals and other health care providers.”
“This initiative is a courageous step forward in addressing the foundational reasons behind both the tragedies caused by drug compounding and the broader issue of preventable drug shortages,” said Peter J. Pitts, President, Center for Medicine in the Public Interest and a former FDA Associate Commissioner. “The anticompetitive manipulation of American healthcare by GPOs is an urgent topic for congressional action.”
The full Congressional release can be found here.
Read More & Comment...BioCentury reports:
FDA issues first breakthrough designation
FDA has "recently" issued the first breakthrough drug designation, Janet Woodcock, director of the Center for Drug Evaluation and Research, said on Wednesday. She said the agency cannot disclose the sponsor or drug candidate. The breakthrough designation, created by the FDA Safety and Innovation Act, commits FDA to collaborate with a sponsor to accelerate product testing and development.
"Drug manufacturing could be the rate limiting step" for implementing the breakthrough drug pathway, Woodcock said at a meeting sponsored by Friends of Cancer Research and the Brookings Institution's Engelberg Center for Health Care Reform. FDA will work with sponsors to improve the chances that manufacturing is scaled-up and approved at the time when breakthrough drugs are approved, she added.
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