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Last September, U.S. regulators faced a dilemma: whether to allow importation of drug ingredients from a Chinese factory (Zhejiang Hisun Pharmaceutical Co.) with a history of poor quality controls, or face shortages of treatments for American cancer patients...Food and Drug Administration inspectors had uncovered what the agency later called “broad data manipulation” at the factory, located in Taizhou....Information about the potency and purity of some product batches had been deleted, making it difficult to investigate a significant increase in customer complaints...The agency issued an indefinite ban on the factory...one of China’s leading exporters of pharmaceuticals products. Yet to avoid possible shortages of drugs, the FDA allowed the plant continue exporting about 15 ingredients for use in finished drugs in the U.S., including nine key cancer medicine components. Hisun says that it takes quality seriously and has complied with requirements.

...AstraZeneca is growing impatient with the U.K. government for not making available the new lung cancer med Tagrisso (osimertinib)...Already available through health programs in France, Germany, Sweden and several other European countries, Tagrisso this week bested chemo in a Phase III trial in advanced EGFR mutation-positive non-small-cell lung cancer. It’s already EU- and FDA-approved, but has so far failed to gain support from NICE (National Institute for Health and Care Excellence), which said on a preliminary basis last month that the drug shouldn’t be included in England’s National Health Service...Anson (AstraZeneca’s U.K. head Lisa Anson) renewed a call for the government to reform NICE, growing the chorus of displeasure among AZ’s pharma peers who have seen effective new drugs turned down on price concerns...

GlaxoSmithKline is recalling a "small" number of batches of its Bactroban antibiotic following a harsh rebuke from US regulators about contamination at a key plant. The move comes after the US Food and Drug Administration sent a stern warning letter late last month to the drug maker about a host of quality-control problems at the facility, which is located in...the United Kingdom...The FDA issued its missive...and found what it called "significant deviations" from good manufacturing practices...The FDA...also noted that the drug maker provided an inadequate response, despite having halted production of the antibiotic and recalling product from wholesalers last year...The letter is the latest attempt by the FDA to bolster the viability of the pharmaceutical supply chain amid a rash of quality-control gaffes. The agency has been attempting to crack down on manufacturers and ingredients suppliers — particularly in India and China — in response to various episodes that led to product recalls and import bans...

U.S. antitrust officials are poised to file lawsuits to block Anthem Inc.’s takeover of rival health-insurer Cigna Corp. and Aetna Inc.’s deal to buy Humana Inc...Justice Department officials, who are responsible for protecting competition, are concerned that the deals, which would transform the health-insurance industry by turning its five biggest companies into three, would harm customers, according to several people familiar with the situation. While the companies may offer to sell assets to gain approval for the deals, that’s unlikely to sway antitrust officials...The final decision on whether to sue to block the deals could come this week or next, another of the people said. The companies could settle a lawsuit before or after one is filed...

Roche won another reprieve in its fight against Accutane safety claims. The...drugmaker persuaded a New Jersey appeals court to overturn an $18 million jury verdict in favor of two Accutane (isotretinoin) plaintiffs...Appellate Division ruled...that the trial court judge "seriously erred" in allowing some revelations in court while restricting others. The judge’s mistakes were weighty enough to warrant a new trial...It’s the latest in a series of victories on appeal for Roche...The lawsuits are among 3,000 assigned to multicounty litigation in New Jersey. The plaintiffs allege that Roche’s acne drug, pulled from the market in 2009, triggered their inflammatory bowel disease...Accutane once was a blockbuster med for Roche and a staple therapy for acne sufferers. Roche pulled Accutane for "business reasons"...long after the drug went off patent and generics hit the market. The company already was facing hundreds of liability lawsuits at the time

The U.S. Food and Drug Administration has become something of a bogeyman for India’s stock market...An inspection blitz on Indian drug factories that supply to the U.S. helped push the broader index of Indian health-care stocks down by as much as 20 percent earlier this year from its all-time high in 2015 after some top firms received warning letters for failing to meet the regulator’s standards...But even as the FDA has increased scrutiny of India, it’s been approving generic drug applications from the country’s firms at a record pace...Everything sounds negative around Indian pharma, but practically it’s just a few companies...India’s growing importance in the U.S. supply of generic medicines -- India Ratings & Research estimates it accounted for 31 percent of all new drug approvals last year -- prompted the FDA to increase its workforce in the country to 19 from 12 in recent years...

Britain's decision to leave the European Union threatens to undermine its position as a center for drug research and UK patients could fall behind others in Europe in getting access to new drugs, Roche's chief executive said..."If certain cutting edge innovative medicines do not become part of the standard of care in the UK, this hampers research and development," Roche CEO Severin Schwan said...Britain has a strong reputation for medical research but it is already a difficult market for launching expensive new drugs, such as the modern cancer treatments produced by Roche...

With the vast majority of drugs and drug ingredients being manufactured outside the U.S., the FDA has had to step up its international oversight and often ban products from plants that don’t meet its standards. But the FDA also has found itself increasingly having to walk a tightrope between drug safety and drug availability...Because of the nature of the business, with companies in China or India often being a primary source of essential drugs, the FDA sometimes must exempt products and allow imports from plants that it believes have a poor record. Since 2013 the FDA has allowed 8 plants whose products are otherwise banned from the U.S. to go ahead and import some drugs or ingredients to avoid shortages, according to FDA Import Alert records.

A Johnson & Johnson subsidiary has agreed to pay $18 million to resolve charges of causing health care providers to submit false claims to Medicare and other federal health care programs, which then paid for a device that was illegally marketed...The settlement...comes...two days after a pair of former executives at...Acclarent, were found guilty of several misdemeanor charges of distributing a misbranded and adulterated device. A federal court...found the executives marketed the Stratus device for a use that was not approved by the Food and Drug Administration... Acclarent won FDA approval to market its Stratus device (Relieva Stratus Microflow Spacer) to be used only with saline to maintain sinus openings following surgery. But the feds alleged the company intended to market Stratus as a drug-delivery device for prescription corticosteroids and maintained the device was specifically designed and engineered for this use...The episode stems from a whistleblower lawsuit that was filed...by Melayna Lokosky, a former Acclarent sales rep...Her lawsuit described the steps that Acclarent had taken to promote the device and allegedly deceive physicians about its efficacy. She is expected to receive about $3.5 million from the settlement.

U.S. antitrust officials on Thursday moved to block an unprecedented consolidation of the national health insurance market, filing suit against Anthem Inc's proposed purchase of Cigna Corp and Aetna Inc's planned acquisition of Humana Inc...The U.S. Department of Justice said the two mergers would reduce competition, raise prices for consumers and stifle innovation if the number of large, national insurers were to fall from five to three..."We will not hesitate to intervene. We will not shy away from complex cases," U.S. Attorney General Loretta Lynch told a news conference. "We will protect the interests of the American people."