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...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.

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.

An Illinois-based psychiatrist has been sentenced to 9 months in federal prison and ordered to pay nearly $600,000 for accepting hundreds of thousands of dollars in pharmaceutical industry kickbacks...Michael J. Reinstein, MD, was convicted of accepting payments from industry in the form of consulting fees, entertainment, and all-expense-paid vacations in exchange for prescribing and promoting first the brand-name version and then the generic version of the antipsychotic clozapine to thousands of indigent elderly patients in Chicago-area nursing homes and hospitals...In addition to the 9-month sentence, ordered by US District Judge Sharon Johnson Coleman, Dr Reinstein was ordered to forfeit $592,000 and perform 120 hours of community service following his release from federal prison...Dr Reinstein fully cooperated with the government in its ongoing investigation into healthcare practices in the Chicago area...In recognition of this cooperation...sentence was reduced to 9 months in a federal prison.

In an amazing display of bureaucratic hubris, the Centers for Medicare & Medicaid Services has proposed a mandatory, real-world experiment with provider reimbursement under the Medicare Part B program…CMS wants to reduce reimbursement for buy-and-bill drugs—but for only half of the country's providers. The other half will retain current reimbursement levels. After five years, CMS will see what happened…the proposal so overreaches that it will face enormous opposition and has little chance of being implemented…CMS’s proposed…Payment Model and the glaring methodological flaw that could end up raising drug costs…CMS wants to go after the buy-and-bill system’s theoretically…incentive for physicians to prescribe more-expensive drugs. For pricey specialty drugs, even a low single-digit markup over ASP can generate substantial dollar profits for a provider…These practices are for-profit private businesses. They will surely attempt to optimize against the CMS Phase I proposal by, for example, strategically directing patients to certain locations based on the cost of therapy and expected reimbursement…CMS even claims that its Phase I proposed model is “budget neutral.” This conclusion is based on the false assumption that there will be no behavior change in response to the study…CMS also ignores the possibility that patients will be shifted to higher-cost sites of care, including hospital outpatient departments…We are already seeing similarly brutal opposition to CMS’s latest brainstorm.

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...

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...

CMS said it plans to add about 1,900 diagnosis codes and 3,651 hospital inpatient procedure codes to the coding system…On Oct. 1, the Centers for Medicare and Medicaid Services will add another 5,500 codes to the ICD-10 diagnostic library, officials announced…The addition will come exactly one year after ICD-10, with its nearly 70,000 billable codes, replaced the dated, and much more compact, ICD-9 code set… The new and revised ICD-10-CM (Clinical Modification) and ICD-10 PCS (Procedure Coding System) codes will be included in the hospital inpatient prospective payment system proposed rule for fiscal 2017…

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.

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 Robert Wood Johnson Foundation released its seventh annual County Health Rankings, which, despite their name, aren’t a competition between U.S. counties to see who’s the best at health. Rather, the report exists to assess all the counties in the U.S. based on factors ranging from tobacco use and access to healthcare to air quality and even education…on the whole and for most of the country, the report doesn’t look terrible. Generally speaking, premature death numbers–a key indicator of overall community health–have been steadily going down. That is, unless you live in a rural area...There are 46 million people who live in rural communities. Nearly one in six Americans lives in a rural area…And the challenges they are facing are showing up in how they are not living as long as other Americans… Many of those rural counties, in fact, are already finding ways to address their local problems by offering services that are otherwise out of reach…some rural areas are getting together with communities nearby and combining to offer services that would be impossible to do alone…