- The People vs Big Pharma: tackling the industry’s trust issues (pharmaceutical-technology.com)
Price hikes, manipulative patent litigation and a rampant opioid addiction epidemic have steadily soured the public’s view of the pharmaceutical industry. Does Big Pharma has (have) a crisis of public trust on its hands, and if so, how might it restore its credibility in the eyes of patients, policymakers and the rest of the taxpaying public?...“I sort of view Big Pharma, as an industry, as an octopus with many tentacles, and at the end of every tentacle is a wad of cash,” says David Mitchell, president...of...Patients for Affordable Drugs...“It reaches into academic medical centres, professional organisations, patient organisations, state houses, campaigns, Congress – they’re everywhere.”...Mitchell’s description sounds more suited to some sinister political conspiracy than an industry whose business is saving lives and curing diseases. But despite the pharma sector’s noble clinical goals, many of the industry’s business practices – monopoly pricing, blocking generics and biosimilars, spending heavily on political lobbying, an arguably relentless focus on profit – have eroded public trust in its credibility and motives.
- Survey data confirms pharma’s trust issues
- Pharma trust: a varied global picture
- Particular challenges in the US
- Trust exercises: the road to redemption
- Community health centers in desperate need of being re-funded (nevadaappeal.com)
Sierra Nevada Health Center is one of Carson City's two federally-qualified health care centers that were hoping for renewed funding at the beginning of this month, but are instead still waiting on Congress to extend the Community Health Centers Fund program that expired on Sept. 30, 2016...Nevada's six federally-qualified health care centers provide care to around 89,000 patients across the state. Sierra Nevada Health Center and Carson City School-based Health Center provide care to Carson City and Carson Valley residents and are hanging in a balance after the deadline to extend the funding passed...Nevada's health centers are among more than 1,300 community health centers across the U.S. that receive funding from the CHCF program. Today, Nevada's health centers employ more than 60 medical professionals...Earlier this month, Nevada Health Centers CEO and board chairs sent a letter to Nevada's congressional delegation to encourage action on funding for community health centers...addressed to Republican Sen. Dean Heller, Democratic Sen. Catherine Cortez Masto, Democratic Rep. Dina Titus, Republican Rep. Mark Amodei, Democratic Rep. Jacky Rosen and Democratic Rep. Ruben Kihuen, the CEO and board chairs asked for unity between political parties and a solution to health care funding...The letter encourages Nevada congressional members "to develop a long-term, fiscally responsible funding plan that ensures the success of our country's greatest public health asset."
- Apple Likes the Patent ‘Death Squad.’ Allergan Pays to Avoid It (bloomberg.com)
Allergan Plc’s decision to pay a Native American tribe $15 million a year rather than let one of its blockbuster drugs be scrutinized by the U.S. Patent & Trademark Office is part of a backlash against an agency review panel that has been dubbed a “death squad.”...The drugmaker earlier this month transferred ownership of patents protecting a medicine with $1.49 billion in sales last year to the Saint Regis Mohawk Tribe of upstate New York. The tribe, which will receive royalties every year, says that as a sovereign entity it is immune from such civil patent challenges....The creative -- and untested -- maneuver is designed to circumvent the Patent Trial and Appeal Board...critics say the board has made it too easy for rivals to attack patents and they’re pressing Congress, the courts and the patent office for changes...companies such as Google or Apple Inc., which are among the biggest users of the review board to fend off what they consider nuisance lawsuits from companies looking for a quick payday...the Supreme Court agreed to take a case to determine if the reviews are constitutional -- critics of the reviews say a patent is a property right that only federal courts can revoke. But even those who want to see the system dismantled say that case is a long shot...The patent office has been considering changes to its procedures...
- The 340B Program Hits $16.2 Billion in 2016; Now 5% of U.S. Drug Market (drugchannels.net)
The 340B Drug Pricing Program’s explosive growth continues...discounted sales hit $16.2 billion in 2016. That’s a 34% increase over the 2015 figure. Consequently, the 340B program accounted for 5.0% of the total U.S. drug market in 2016...Covered entities are generating billions in untraceable profits from this fast-growing program. Hospitals, which make up the vast majority of 340B purchases, should be required to account clearly for the billions the program provides them...Some hospitals have published high-level descriptions of how they spend 340B funds, but none of the articles fully accounts for the billions of dollars in 340B profits. Much more transparency is required, because the dollars are very large and growing very quickly…Given the program's rapid growth and its channel distortions, Congress urgently needs to refocus the program on genuine safety-net providers and financially needy patients.
- FDA seals loophole that allowed some drugmakers to avoid pediatric clinical trials (medcitynews.com)
PREA loophole had allowed companies to receive orphan drug designations for diseases common in adults...The Food and Drug Administration moved...to close a loophole that had inadvertently excused some drugmakers from having to conduct clinical trials in children for drugs to treat diseases that commonly affect adults...the FDA announced that it had finalized a draft guidance...intended to close a loophole in the Pediatric Research Equity Act that allowed drug companies making medicines for non-orphan diseases in adults – meaning those affecting more than 200,000 patients – to get pediatric subpopulation designation. Consequently, companies were exempt from conducting the clinical trials in children that PREA would normally have required...“Addressing the inadequate testing of drugs in pediatric populations has been a priority for the FDA, the medical community and Congress and has led to important laws to ensure this important, vulnerable population is not overlooked,” FDA Commissioner Scott Gottlieb said...
- Nevada explores options as Children’s Health Insurance Program expires (reviewjournal.com)
Nevada officials are exploring alternative avenues for insuring more than 26,300 children in the state covered under the Children’s Health Insurance Program if Congress doesn’t reauthorize the program, which is set to expire Saturday...Congress is expected to reauthorize the CHIP program through a bipartisan bill, though that could be weeks away. And with the turmoil in Congress lately, state officials are taking no chances...The Department of Health Care Financing and Policy is working with state partners to identify alternative sources of funding for the program if it is not reauthorized, deputy administrator Cody Phinney said ...“We would have to find other funding sources and we’d have to look at our options for limiting the services that are available, but our first role is to maintain those services,” Phinney said...the federal government pays nearly the entire annual $43 million cost of the program in Nevada...The state has ‘reserve funding’ to operate the health-care program for the next few months. However if Congress does not quickly reauthorize CHIP, states like Nevada will need to either send notices of termination to program beneficiaries or develop alternative funding...
- How do you get lower cost drugs? Give the FDA a bigger stick (thehill.com)
Regulation can be a tool to strengthen competition and address important health and safety concerns, but it can also be abused to limit access to the market...lawmakers and regulators must regulate wisely and be careful of unintended consequences...what happens when important safety regulations can be gamed by bad actors seeking to preserve their monopoly profits?...This has been happening in the market for generic drugs, where some dominant brand name pharmaceutical companies are trying to shut out low cost generic competitors by manipulating the regulations originally designed to keep people safe. And this is not a small problem, either…The problem comes from a conflict that arises between...Risk Evaluation and Mitigation Strategy, and the approval process a generic company needs to go through to enter the market once a drug patent expires. Generics must get a sample of the brand name drug they want to compete with to prove to the FDA that their product is exactly the same...the REMS program greatly restricts access of certain drugs unless proper safety protocols, unique to each drug, are met. This can leave generic companies with no choice but to ask for samples directly from the manufacturer...It is not surprising that these drug makers are denying generics access to these samples. However, the FDA currently does not have the tools necessary to discipline these bad actors and force the distribution of samples to generic companies...Congress is now paying attention...
- NIH Targets $500 Million At Opioid Crisis (forbes.com)NIH leadership outlines interdisciplinary FY2018 research plan for HEAL Initiative (nih.gov)
The National Institutes of Health is explaining how it will spend $500 million in research funds Congress appropriated to address the current opioid crisis...The list of objectives, published...in the Journal of the American Medical Association, includes: developing new medications to treat opioid addiction; tinkering with existing medications so they can be taken less often; improving medicines that reverse overdoses; developing new models of caring for people with opioid addiction in the healthcare and criminal justice systems; determining the best way to care for newborns in opioid withdrawal; discovering and validating new targets for non-addictive pain drugs and devices, and partnering with pharmaceutical companies to accelerate new pain and addiction medications. The $500 million will be distributed as research grants after a call for proposals later this summer.
- Future uncertain for Nevada health insurance exchange due to Obamacare threat (reviewjournal.com)
Business will continue as usual for Nevada’s Silver State Health Insurance Exchange during the upcoming open enrollment period despite uncertainty over its future in Congress...Insurance exchange officials, joined by Democratic state Sen. Yvanna Cancela, addressed advisers who will help with the enrollment process ...emphasizing the need for aggressive outreach to Nevada’s estimated 43,000 eligible but non-enrolled residents...They also said planning will continue ahead of the Nov. 1 beginning of the enrollment period despite the potential that Congress could eliminate the exchange by repealing the Affordable Care Act...
- It’s time to make it legal for Americans to order prescription drugs from abroad (statnews.com)
Every day, countless people across America order prescription drugs from pharmacies in other countries as they hunt for something increasingly elusive — affordable medications...Under most circumstances, importing medicines is illegal...And it is time to scrap this prohibition, unless Congress finds another way to drive down drug costs...Sixty percent of Americans say lower drug costs should be a top priority, and a whopping 72 percent support the idea of importing medicines from Canada, according to a recent Kaiser Family Foundation poll...8 percent of adults surveyed reported that they or someone in their household have already bought prescription drugs from outside the U.S...Meanwhile, the cost of 20 widely used drugs is three times cheaper in Canadian than in New York pharmacies...