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New York Governor Andrew Cuomo has become the latest entrant in the escalating war over rising drug prices with a budget provision that would effectively cap prices and require drug makers to provide a raft of information about their costs...proposal marks yet another high-profile attempt to force the pharmaceutical industry to respond to the intensifying clamor over the cost of medicines...Under the proposal...the state health department would "develop a list of critical prescription drugs for which there is a significant public interest in ensuring rational pricing." The department would then assess the value of the drugs in order to set a "ceiling price" and could require a minimum rebate to the state Medicaid program...the administration wants companies to provide data about development, manufacturing, and marketing costs for drugs on this list...also require drug makers to submit information about the prices charged other purchasers in the state and outside the United States, any rebates offered customers, and profit margins...the Pharmaceutical Research and Manufacturers of America...have "significant concerns" with the proposal..."Not only will implementing price controls have a very negative impact on innovation and send a signal that risk taking will not be rewarded, but also the so-called ‘transparency’ information called for in the proposals would be virtually impossible to achieve because it does not include the cost of failures inherent in the search for new treatments and cures.

Master Herbs, Inc. (Ma Ying Long Pharmaceutical Group) is voluntarily recalling ALL LOTS of Licorice Coughing Liquid, cough syrup in 100 ml bottles to the consumer level. This product has been found to contain morphine, which is an opioid, and it is not declared on the label. Opioid is an ingredient of Compound Camphor. Compound Camphor is declared on the label of the product, but not its ingredients...The product is used for the temporary relief of cough due to cold, minor throat and bronchial irritations...identified by the Chinese Product Name: Licorice Coughing Liquid The product was distributed to Chinese grocery stores in various cities in California, New Jersey, Hawaii, Illinois, Ohio and Nevada.

Johnson & Johnson is facing yet another lawsuit over its antibiotic Levaquin from people who claim that the company hid serious side effects. The latest legal action comes a couple of months after an FDA panel flagged serious problems associated with the entire class of antibiotics and voted to change the meds' labels...Five plaintiffs allege in a new suit that J&J and its Janssen unit deliberately mislabeled and misbranded Levaquin (levofloxacin), playing down harmful side effects for its own financial gain. The plaintiffs sued J&J and others--including former FDA commissioner Margaret Hamburg--under the federal Racketeer Influenced and Corrupt Organizations act, a law typically used to prosecute organized crime. "These concerted efforts resulted in significant harm and/or death to consumers of Levaquin, including plaintiffs," according to the suit...The plaintiffs are seeking more than $120 million in compensatory damages and more than $750 million in punitive damages to drive home "the seriousness of their egregious conduct and to deter similar conduct in the future."...The latest suit marks another chapter in J&J's Levaquin saga. The company has encountered thousands of lawsuits over the past several years from plaintiffs claiming that it did not adequately warn patients about the drug's dangers.

As part of a new "strategic roadmap" unveiled recently, Sanofi plans to announce layoffs that are being described as "sizable" and that will affect a broad swath of company operations in various locations. Some cuts are expected to be...in France, where the drug maker is headquartered, although extracting concessions from French labor unions is notoriously difficult. As a result, a disproportionate number of job losses may occur in the United States. A layoff notice, in any event, is expected to be filed shortly with state officials in New Jersey, where Sanofi maintains a large corporate campus...The drug maker...employs about 110,000 people worldwide, including roughly 17,000 people in the US...Sanofi encountered price discounting in the long-acting insulin market...This was thanks to its Lantus product, which generated about 18 percent of sales in the first half of last year, but faces pressure from payers seeking discounts...a follow-on product is not showing signs of generating needed replacement revenue and a biosimilar version of Lantus will become available at the end of this year. And a deal to sell the MannKind inhaled insulin product known as Afrezza was just ended due to terrible sales.

Dr. Blair Thielemier interviews pharmacist & entrepreneur – Simone Sloan about what drives entrepreneurship, leadership, and transforming our pharmacy industry. (23:19 min)

China, which manufactures most of the ingredients for Western products, has a reputation for having some pretty questionable manufacturing operations. Czech inspectors got a firsthand look at one plant that they said posed "extreme risks" to consumers...According to two reports on the plant posted by the European Medicines Agency, authorities dropped by the Huanggang City facility of Hubei Hongyuan Pharmaceutical in October after the plant had been mentioned as an intermediate manufacturing site for the antibiotic metronidazole. The company acknowledged in its introduction that the site didn't follow EU GMP standards, the report says. During a walk-through, inspectors confirmed that...They said they found a plant in a devastated state, with "huge layers of dust and product" that indicated that neither the plant nor the equipment was being cleaned or that equipment was being maintained. It was noted the situation posed "an extreme risk of cross-contamination." Additionally, almost none of the products that they saw had been labeled and there was no batch manufacturing documentation...Western authorities have stepped up inspections of Chinese plants, both of those owned by Chinese companies and those owned by Western drugmakers, and found problems in both cases.

Look out, pharma: Britain's competition watchdog is coming for you....The U.K.'s Competition and Markets Authority is planning to levy "substantial fines" this year, marking a "big step up in the scale and impact" of its enforcement activity, Alex Chisholm, head of the agency, told the Financial Times. And one of those fines will likely be directed at a pharma company...The CMA has been probing drugmakers including GlaxoSmithKline and Pfizer for alleged wrongdoing. "In high-value markets with big players, they should face big fines,"...For Pfizer, though, a resolution could still be a ways off. In August, the CMA accused the drugmaker and partner Flynn Pharma of running afoul of U.K. and European laws by jacking up costs for their epilepsy drug...The pair charged "excessive and unfair prices"...the CMA said at the time, raising costs by as much as 2,600%. Regulators plan to hand down a decision in the case in about three months..."While businesses are generally free to set prices as they see fit, those that hold a dominant position have a special responsibility to ensure that their conduct does not impair genuine competition and that their prices are not excessive and unfair,"...

All Party Pharmacy Group has warned...Between 1,000 and 3,000 pharmacies — as many as one in four — could close in England as a result of government cuts to funding for pharmacy...A letter to the Pharmaceutical Services Negotiating Committee in December 2015 announced a 6% funding cut from £2.8bn ($4bn) to £2.63bn ($3.7bn)...there would be further reductions in future years...there is also much more to this picture than a cut in funding. There is a clear intention to reduce the number of pharmacies...In some parts of the country there are more pharmacies than are necessary to maintain good access. 40% of pharmacies are in a cluster where there are three or more pharmacies within ten minutes’ walk...The Department will separately consult on changing the Human Medicines Regulations 2012 to allow all pharmacies to access the efficiency created by ‘hub-and-spoke’ dispensing...This could help pharmacies to lower their operating costs and free up pharmacists to provide more clinical services and public health services...the government would not decide which pharmacies should close. Pharmacies would need to decide whether they were "viable" in light of the change to the funding level. He admitted that independents will be "squeezed" and that this is a matter of concern for the government to look at...Warehouse dispensing, or ‘hub and spoke’, raises questions around safety, quality and access...The supply of prescription medicines cannot be treated like buying clothes and DVDs. High quality, safe dispensing depends on the opportunity for a face-to-face discussion between the pharmacist and the patient. I don’t see how that can be done in a warehouse.

The Association of Medical Media plans to hold a meeting to establish an industrywide viewability standard...A group of medical publishers will attempt to develop a new industry standard for digital advertising viewability, a much debated topic that has vexed the broader advertising industry...Viewability—how long is long enough for a user to have viewed a digital ad successfully—has cropped up in recent years as one of the more challenging media issues, and one that needs to be addressed as the business of digital advertising matures. In healthcare, experts say, it's no different..."There's more pressure to account for dollars,"...The group's perspective is that professional medical content differs from other online advertisers..."It is distinguished from general web content in many ways, including in its scarcity and its value to the end reader...industry experts have been saying that drugmakers will likely put more emphasis on digital advertising as brand marketing becomes more targeted to certain patient populations and manufacturers lose direct access to physicians and other prescribers. That could expose more advertisers to the vagueness of viewability and highlight the need to find a solution that makes sense given the nuances of medical advertising, notably content aimed at healthcare providers.

In the first enforcement action from the FDA's marketing police this year, the Office of Prescription Drug Promotion put Hospira in the hot seat over a YouTube video for its sedative Precedex (dexmedetomidine)...The OPDP sent an untitled letter dated Jan. 14 to the Pfizer-owned company, charging the video "omits risks and material facts" about the drug. The agency also rebuked Hospira for publishing the promotional video without submitting it to the OPDP for review...The letter orders Hospira to "cease violating the FD&C Act, as described," and submit a written response before Jan. 29. The response should include a plan for "discontinuing use of such violative materials," the letter states.