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IACP Members Go to the Hill with Three Actionable Asks

This year, IACP went to the Hill with three Asks, each with a Congressional action item. IACP and its legislative team have worked tirelessly for the past year emphasizing FDA should be implementing DQSA (Drug Quality and Security Act) according to congressional intent!

• Issue #1 Support Pharmacists: Sign the Bipartisan Letter to FDA Led by Representatives Chris Stewart and Henry Cuellar.
• Issue #2 Support Letter to Chairman Chaffetz and Ranking Member Cummings to Request House Oversight and Government Reform Hearings on FDA's Implementation of DQSA.
• Issue #3 Support Pharmacists: Sign the Senate Letter to FDA Regarding Office-use.

As China's medical bills rise steeply, outpacing government insurance provision, patients and their families are increasingly turning to loans to pay for healthcare, adding to the country's growing burden of consumer debt...While public health insurance reaches nearly all of China's 1.4 billion people, its coverage is basic, leaving patients liable for about half of total healthcare spending, with the proportion rising further for serious or chronic diseases such as cancer and diabetes...Medical loans are just part of China's debt mountain - consumer borrowing has tripled since 2010 to nearly 21 trillion yuan, and in eight years household debt relative to the economy has doubled to nearly 40 percent...

A Juno Therapeutics Inc trial of its experimental cancer therapy, known as JCAR015, was put on hold by U.S. regulators after the deaths last week of two leukemia patients…Shares of Juno fell 30 percent...in after-hours trading...A third trial patient died in May...All three patients were in their 20s, and the deaths were linked to swelling in the brain…JCAR015 is a chimeric antigen receptor T-Cell, or CAR-T, therapy, involving a complicated process of extracting immune system T cells from an individual patient, altering their DNA to sharpen their ability to spot and kill cancer cells, and infusing them back into the same patient...Juno said the deaths occurred after the chemotherapy agent fludarabine was added to the trial program. The company said it has proposed to the U.S. Food and Drug Administration that the trial be continued using JCAR015 with just cyclophosphamide as a "pre-conditioning agent."...the FDA asked that the company submit a revised patient consent form, investigator brochure, trial protocol, and a copy of the presentation made to the agency on Wednesday. Juno said it plans to submit the requested information to the FDA...

Pfizer reached an agreement with the city of Chicago to follow a code of conduct for marketing opioids that officials hope will become standard practice for other companies...The drug maker agreed last week to disclose in all promotional materials that opioids carry a risk of addiction and not to promote them for any unapproved uses...Pfizer must make clear that there is insufficient research about the effectiveness of opioids if used beyond 12 weeks…Some industry watchers, meanwhile, said that the four-year agreement, which does not pertain to any other city or state, largely requires Pfizer to adhere to existing laws and regulations governing drug marketing. For this reason, they said the agreement breaks little new ground in the battle against inappropriate or overprescribing of opioids..."This landmark agreement is a big step in the right direction to help protect and educate the public about the true risks and benefits of highly potent and highly addictive painkillers," said Chicago Mayor Rahm Emanuel in a statement...It’s in Pfizer’s interest to highlight the addictive properties of opioids because they have a competing product under development (tanezumab)...When a company comes out slamming a particular class of drugs, it’s generally because they have a competitor in the wings. Think of this as prelaunch marketing, which can start long before the launch...

In its latest (to) bid to set parameters around compounding, the US Food and Drug Administration...issued a pair of draft guidelines to clarify when compounding pharmacies are permitted to make versions of commercially available medicines...federal law currently states that a compounder generally shouldn’t make copies of drugs that are approved for sale, the agency is getting more specific and wants to ensure that a true clinical need exists before a compounded version of an approved medicine drug is made for a patient...A key issue has been the extent to which compounders can make medicines for patients in ways that may cross the line into more conventional drug manufacturing. The new law attempts to create boundaries, although the latest guidelines are designed to refine the FDA interpretation... the guidelines would permit compounders to make versions of brand-name drugs when a shortage exists or the brand-name medicine has been discontinued. Another example meeting the threshold of patient need might be a required change in formulation...But safety is not the only issue in play here. For instance, pointing to a lower price...a compounded version would be cheaper than a brand-name drug — is not justification for compounding an FDA-approved medicine...these are only draft guidelines — guidances in regulatory parlance — and are not set in stone.

Less than one month following Walgreens decision to terminate its relationship with Theranos, the blood-testing lab on Thursday announced that the Centers for Medicare & Medicaid Services has revoked the company's CLIA certificate, among other sanctions. The revocation of Theranos' CLIA certificate precludes the owners and operators of Theranos from owning, operating or directing a lab until at least July 2018...In addition to the revocation of Theranos' CLIA certificate, the full list of CMS sanctions include:

• Limitation of the laboratory’s CLIA certificate for the specialty of hematology;
• A civil money penalty;
• A directed portion of a plan of correction;
• Suspension of the laboratory’s approval to receive Medicare and Medicaid payments for any services performed for the specialty of hematology; and
• Cancellation of the laboratory’s approval to receive Medicare and Medicaid payments for all laboratory services.

Alibaba Health Information Technology Ltd…the subsidiary of China’s biggest e-commerce operator is attempting to revive its fortunes by tapping new areas of growth -- like consumer safety...China...scrapped plans to implement a compulsory drug coding system intended to identify counterfeit medicines that would have used a platform developed by Ali Health. The Alibaba Group Holding Ltd. subsidiary says it is now using the same technology to build a commercial tracking platform that will have wider applications beyond medicines...Ali Health’s new system could be used to track the origins of products such as baby formula, farm produce and even wine for Chinese consumers concerned about food safety…Ali Health is currently talking to partners to expand use of the technology, and continues to run the existing drug tracking system for the government while awaiting a final decision. The China Food & Drug Administration suspended the electronic coding system earlier this year for use in the drug industry as it made draft amendments to existing rules, allowing the use of other methods to track medicines back to their origin...

A closely watched skirmish over the cost of prescription drugs has ended in defeat for a company that sought to challenge the right of a Canadian agency to impose a price cap on a pricey medicine...Canada’s Federal Court dismissed a constitutional challenge that Alexion Pharmaceuticals filed against the Patented Medicine Prices Review Board, which...sought to keep a lid on the cost of the company’s Soliris (eculizumab) medication...The...agency had asked Alexion to lower its price and repay sales generated by the drug from 2012 through the first half of 2014..."It is far from surprising," said Richard Gold, a professor at McGill University..."Alexion may still appeal in hopes that the Supreme Court of Canada will alter the law. I think the [possibility that the court will find] the provisions unconstitutional are remote. Parliament can create and limit patent rights as it wishes, but pharmaceutical companies have been known for being obstinate in the face of logic."

A dozen doctors hold a hunger strike in the corridors of an Andean city hospital. In another provincial city, hundreds of protesting medics suspend appointments...With eight out of 10 medicines now scarce, according to the main pharmacy group, protesting doctors are demanding that President Nicolas Maduro's socialist government declare a national health crisis and allow foreign humanitarian aid...In June, Pino (Christian Pino, a surgeon at the Merida hospital) read a list of doctors' demands in Venezuela's National Assembly before the opposition-led legislature declared a state of medical emergency and approved channels for foreign humanitarian aid...But the...Supreme Court shot down the assembly's proposal. Government officials deny Venezuela is facing a humanitarian crisis and say there is no need for humanitarian assistance...Idabelias Arias, the head of the emergency ward at a pediatric hospital in Barquisimeto..."Doctors are doing war medicine here."

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.