Category:

EU antitrust regulators this week cracked down on Apple, ordering the American tech giant to fork over about $14.5 billion in taxes--plus interest--to the Irish government. The watchdogs had decided that Apple's profit-routing scheme through tax-advantaged Ireland was illegal...Gilead Sciences might be in line for a similar European crackdown. But one U.S. advocacy group--which wants similar justice for Gilead--marks one crucial difference: It wants the California-based biotech to pay the tax bill at home...Americans for Tax Fairness penned a letter to U.S. Treasury Secretary Jacob Lew and Commissioner John Koskinen, drawing attention to alleged tax-avoidance moves by the drugmaker. The group says moving sales through Ireland increased Gilead's pre-tax profits fivefold between 2013 and 2015--from $4.2 billion to $21.7 billion. The moves also triggered a threefold jump in untaxed offshore profits, from $8.6 billion to $28.5 billion...

After years of anticipation, the Food and Drug Administration will hold a public, two-day meeting in November to review the extent to which so-called off-label information about medicines may be disseminated to physicians...the FDA has taken a firm stance toward the issue. A key concern is that public health could be jeopardized if a company were to distribute information about an unapproved use that had not been proven to be safe and effective, a standard for regulatory approval...drug makers have argued that conveying certain types of information is protected by the First Amendment...drug makers and their supporters have grown impatient and fear that various court rulings might become a de facto standard. Last winter, an independent review panel was floated as a way to address the issue. Last May, two lawmakers accused the Department of Health and Human Services of delaying new rules and issued a draft bill that would allow companies to market products for unapproved uses...

The top law enforcement official in New Hampshire...accused the manufacturer of OxyContin...of stonewalling demands for information the company collects about suspected criminal trafficking of its painkiller..."They are just refusing to turn over documents," state Atty. Gen. Joseph Foster said of drugmaker Purdue Pharma..."On one hand, they tell us they have nothing to hide and they are doing everything appropriately, but then why are they fighting so hard not to turn over this information?"…In refusing to comply with the...subpoena, Purdue cited longstanding objections to the state’s use of a private law firm in an ongoing investigation of the company and other opioid makers…company lawyers have said Purdue is willing to provide records to the attorney general and his lawyers, but on the condition they not share them with the private attorneys, who they have suggested have a financial incentive to wrest multimillion-dollar judgments from the company in civil suits.

Any program that puts more greenbacks in patients' pockets in this post-recession economy has to be viewed as a good one, right? Alas, it depends on the person you ask...Devised to shoulder some of the cost burden of prescription drugs, manufacturer co-pay card programs have been tied to improved adherence rates and reduced barriers to the discounted medications. At the same time, payers — insurers and PBMs alike — are crying foul...While some industry veterans sing the praises of co-pay assistance programs, others are eager for a more evenhanded and efficient solution that will achieve the same degree of cost savings. In fact, the co-pay card appears to be stirring the controversy pot more than ever. Indeed, the question seems to have become: What will make it boil over?

Non-profit organizations across the country were awarded grants Wednesday from the Cardinal Health Foundation to help fight prescription drug misuse by improving their communities' medication disposal programs..."One of the simplest and most effective ways to fight prescription drug misuse is to encourage the proper disposal of unused or expired medication," stated Betsy Walker, community relations director and Generation Rx program manager at Cardinal Health. "Cardinal Health Foundation is investing $360,000 to support these programs and help educate on proper disposal."…All grant projects are required to measure impact and outcomes of the disposal program's promotion efforts and education efforts (comparing community participation in drug disposal before and after program implementation, for example). In addition, each grantee is charged with seeking opportunities, if available, for scaling up and spreading successful programs to other communities...

U.S. regulators said...that AstraZeneca will pay $5.52 million to resolve a foreign bribery probe into improper payments by its sales and marketing staff to state-employed healthcare officials in China and Russia...The U.S. Securities and Exchange Commission detailed the settlement with the London-based drug company in an order instituting an administrative proceeding arising out of violations of provisions in the Foreign Corrupt Practices Act...AstraZeneca, which cooperated with the probe, neither admitted nor denied wrongdoing…SEC said that AstraZeneca through at least 2010 failed to devise and maintain a system of internal accounting controls relating to its subsidiaries' interactions with Chinese and Russian government officials...Sales and marketing staff in those countries...provided gifts, conference support, travel, cash and other benefits to the state-employed healthcare providers to buy or prescribe the company's products...

Walgreens Boots Alliance Inc said it would partner with pharmacy benefit manager Prime Therapeutics to reduce drug procurement costs...The companies will combine their central specialty pharmacy and mail order service businesses and introduce a new retail pharmacy network that will give Prime Therapeutics' customers access to Walgreens' pharmacy network...Walgreens...already has partnerships with PBMs such as Express Scripts Holding Co...and UnitedHealth Group Inc's OptumRx...Walgreens is also in talks to acquire Rite Aid Corp, which will give it ownership of Rite Aid's PBM, EnvisionRx...

This is a picture of Josh Hardy...Josh...had undergone a bone-marrow transplant for kidney cancer...He was dying...There was an experimental drug called brincidofovir...his doctors thought might work. But the company declined their repeated requests to provide it. His parents...rallied friends, who rallied their friends and their friends...until it seemed as though the entire Internet were behind them...The ending was a good one: The company gave Josh the drug, and it worked and he got to go home...But not all cases like this go so well. A powerful report from STAT this week provides a heartbreaking reminder that the reason experimental drugs are not available for anyone to use is because they are just that — experimental. And the chances that things will go wrong are as strong as that they will go right...

The pharmaceutical industry theme song may be Joan Jett’s "Bad Reputation."...Of 25 different business sectors, only the federal government is held in lower esteem by most Americans, according to a recent Gallup Poll. What’s more, the pharmaceutical industry last year registered its worst showing in the 16 years that Gallup has been tracking how different sectors are perceived...The findings are not all that surprising. There may be a steady stream of stories about new medicines that are producing unprecedented patient outcomes in tackling such hard-to-treat diseases as cancer and hepatitis C. But the ongoing controversy over the cost of prescription drugs may be overshadowing many of the advances made by the pharmaceutical industry...

In a closely watched decision, the California Supreme Court ruled 4-3...that hundreds of out-of-state residents had the right to sue Bristol-Myers Squibb in the state court system over side effects caused by one of its drugs...At issue was the question of jurisdiction, which can be used to determine where a lawsuit may be filed. This particular ruling clarified the extent to which the drug maker needed to have a presence in California in order to be sued by people from Texas, Ohio, and 33 other states, who claim they were harmed by the Plavix blood thinner...Although Bristol-Myers may not be headquartered in California, the court determined the company conducts enough business — sales, marketing, distribution, and R&D — for state courts to serve as a venue for lawsuits filed by out-of-state residents...the ruling applies only to this particular case, the court may have hung a welcome sign that invites still more people from around the country to file lawsuits in California against drug makers...That’s because California state courts are seen as more hospitable to people who bring lawsuits against drug makers...