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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.

National Institutes of Health officials just wisely rejected a petition, supported by 51 congressmen, to exercise "march-in" rights to discourage drug "price-gouging." The proposal didn't merely violate the explicit intent of a decades-old statute — the Bayh-Dole Act — it also revealed the legislators' ignorance of drug development and would have devastated medical innovation, while doing nothing to bring down drug costs...The act allows the federal government to "march in" and seize the intellectual property rights of the inventor and grant a license to "a responsible applicant or applicants" under two highly unlikely conditions...First, if the patentee and its licensee have not taken effective steps to achieve "practical application" of the subject invention — in other words, if they're just sitting on it — the government can license the patent to someone who will develop it...The second condition is met when government action is necessary to alleviate health or safety needs that are not being satisfied by the rights holder...march-in rights would not necessarily lower drug prices. March-in rights do not empower the government to control prices — they only allow the NIH to increase competition by giving additional companies the right to utilize drug patents that were directly derived from the government-funded research...Encouraging the government to seize patent rights in a non-emergency situation is a great way to discourage firms from developing and producing any new drugs...

Based on the latest update to the Center for Drug Evaluation and Research’s Manual of Policies and Procedures, the Food and Drug Administration is looking to create more competition among generics — particularly for generics made by a single manufacturer... The updated MAPP outlines situations in which abbreviated new drug applications submitted by generics manufacturers will be eligible for an expedited review process, including submissions related to drug shortages, and legal requirements. Among them is the potential for expedited review for ANDAs related to what the agency calls "sole-source drugs" — drugs whose generic is manufactured by a single company...Submissions for drug products for which there is only approved product listed in the Prescription Drug Product List…of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations...and for which there are no blocking patents or exclusivities may receive expedited review...

...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.

Jon Roth, CEO of the California Pharmacists Association, explains how pharmacists can help prepare their patients for natural disasters.

Theodore Pikoulas, PharmD, BCPP, the Associate Director of Behavioral Health Pharmacy Programs for Community Care of North Carolina, discusses the roles that pharmacists can play on interdisciplinary health care teams.

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...

Hoping to save a few bucks on your prescription, or just trying to avoid a trip to the drugstore?...While mail order can be a good option, it can also be a hassle, and savings aren’t guaranteed...using mail order can be easy, it could lead to communication errors or safety problems...The problem...is that medications may not arrive on time, which can be dangerous for people who rely on lifesaving drugs...The opposite problem can happen, too: Mail order pharmacies might auto-renew your prescriptions without confirming you’re still taking a drug or whether your dosage has changed. When possible, pick a service that will alert you before they ship out any medication...Medicare Part D drug plans require mail order pharmacies to get the okay from a patient or caregiver before shipping a new prescription or refill...Whether you shop in store or by mail order, once you find a pharmacy that fits your needs, our medical consultants strongly recommend you fill all your prescriptions there whenever possible. That way one pharmacy has a complete record of what you’re taking and can flag any potentially dangerous interactions. That might not be feasible, say, if you get your blood pressure drug through mail order and your doctor prescribes a post-surgery pain medicine that you need right away. When that happens, let each pharmacy know all the medications you're taking and update them regularly on any changes.

Benzer Pharmacy, listed in the top 30% of fastest growing companies by Inc. magazine in 2015, announced... that it is looking to expand the reach of its more than 50 locations in nine states by offering a franchise opportunity to independents...Benzer Pharmacy is now offering a franchise opportunity for those looking to start a new pharmacy and a conversion opportunity for pharmacies currently in operation...To thrive in this industry, independent pharmacy owners need to collaborate under one unique yet individual brand...Benzer Specialty Pharmacy offers a hub and spoke specialty model for independent pharmacies. The pharmacy is currently in process of getting accredited with the Accreditation Commission for health Care for specialty pharmacy...