Author: Peter

Erin Albert, Pharm, LLC, CEO and Career Coach (podcast 26:12 min)

When US lawmakers convened a hearing last month to discuss the pricing of prescription drugs, it was the testimony of Martin Shkreli...that garnered the headlines. But the hearing also looked at an issue that...could make drugs more expensive for far more people…The impetus was October’s announcement from Walgreens...that it was buying Rite Aid...Critics said that would create a drugstore duopoly with CVS, the market leader. They didn’t, however, look as hard at another effect of the deal, which likely will bring about the final collapse of the industry tasked with keeping prescription-drug costs under control...Buried inside Rite Aid is a bundle of pharmacy benefit managers...Walgreens says that acquiring Rite Aid’s PBMs would help it compete with arch-rival CVS, which controls a large and extremely profitable PBM called Caremark...combining pharmacies and PBMs under one roof creates a conflict of interest. It can restrict patients’ access to certain prescription drugs, and can prevent independent drugstores from competing fairly for new customers...As "competition decreases,"..."prices are going to increase. That’s what we’re finding now." If Walgreens successfully acquires Rite Aid and its PBMs, one of the industry’s last remaining constraints on drug prices will disappear.

Les Funtleyder, Asset Management Portfolio Manager at ESquared, gives his take on Valeant Pharmaceuticals and the pharma and health care sectors.

Food and Drug Administration has warned Indian generic drugmaker Emcure Pharmaceuticals, saying it repeatedly fudged test records at its plant in western India, in another case of a pharmaceutical firm in the country facing such action...the FDA...found "significant violations" of standard manufacturing practices...The agency had already banned imports from the plant...except for some drugs...It is one of 42 drug-making factories in India that the FDA has banned in recent years as it stepped up inspections of foreign suppliers. The increased scrutiny has hit growth at Indian companies the hardest, as the country supplies nearly 40 percent of the medicines sold in the United Stares...We observed multiple examples of incomplete, inaccurate, or falsified laboratory records...The fabricated records were of tests that Emcure was required to conduct to ensure proper environmental control was maintained while aseptic filling of drug batches, so that the products wouldn't become contaminated...The company has 15 days to respond to the FDA's letter on the corrective actions it will take on the concerns raised.

Jeffrey Fudin, PharmD, DAAPM, FCCP, FASHP, discusses and debunks the myths and hysteria surrounding the use of opioid therapy in treating non-cancer pain.

...Centers for Medicare & Medicaid Services spends $20 billion a year for drugs under Part B, which are those given in doctors’ offices and hospital outpatient centers. Many cancer treatments are provided that way, as are some treatments for rheumatoid arthritis, macular degeneration...Under a proposed rule, different methods would be tried in selected geographic areas over a five-year test period. Some of these experiments would begin this year, with others added in 2017...Dubbed "value-based pricing," such largely unproven ideas are the latest tactics being tried to slow growth in prescription drug spending amid rising public alarm about drug prices...The goal is to test whether alternative approaches will lead to better value...There is no perfect payment system, they all have upsides and downsides...What we don’t want to do is create a world where doctors only prescribe the cheapest stuff even if not in the interest of the patient...Here are four concepts the government is investigating:

1. Cut drug reimbursements for doctors and outpatient hospital centers.
2. Level payments.
3. Tie payments to effectiveness.
4. Cut patients’ out-of-pocket costs.

...the Food and Drug Administration...made a policy change that may prevent companies from pulling a Martin Shkreli...The agency plans to expedite reviews of applications for generic drugs where only one treatment is currently sold. The shift was prompted by public outrage that erupted last fall when Turing Pharmaceuticals...bought a life-saving drug called Daraprim and promptly jacked up the price by 5,000 percent...We identified a gap and were able to identify a path forward...The change being made (allows the agency) to capture circumstances when the only approved product on the market is a generic drug...Even though Turing does not hold a patent on the medicine...company was able to increase the price as it did because there was no generic competition. The drug maker runs a closed distribution system, and as a result, Turing has a monopoly on Daraprim...This should provide a faster way to inject competition in the marketplace, so that the price gougers can’t get away with what they’re doing...the policy change is retroactive, which means the agency will review pending applications to see if any merit an expedited review.

University of Nevada School of Medicine matched 64 of its graduating class with residency programs all over the country Friday morning. The reveal on where students will do residency programs was a surprise until each opened boxes listing programs...Kaleb Wartgow was one of the nearly 30,000 medical students in the U.S. matched to residency programs at hospitals around the country...But Wartgow...from the 2016 graduating class of the University of Nevada School of Medicine, is likely just one of a few absolutely sure he wants to someday practice family medicine in rural Nevada...He was one of 64 from...the...class of 2016 that found out Friday where they will spend the next few years of training. Wartgow, who grew up in Gardnerville and is a 2006 graduate of Douglas High, said he hopes to someday practice medicine in Smith Valley...

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.

Amgen Inc. won a legal victory over Regeneron Pharmaceuticals Inc. in an intellectual property battle over their cholesterol-reducing drugs. Regeneron said it would appeal the decision...A federal jury...rejected Regeneron’s challenges and ruled in Amgen’s favor that two of its patents on its drug, Repatha (evolocumab), were valid...Sanofi and Regeneron said after the verdict that they plan to appeal, reiterating their position that Amgen’s patent claims are invalid. They had claimed that Amgen hasn’t fulfilled requirements to describe clearly what it had invented in a way that others could understand...Amgen...is thankful that the jury weighed the evidence carefully and recognized the validity of Amgen’s patents on Repatha...With the decision, Regeneron and Sanofi are liable for royalties...The companies may reach a settlement with Amgen...