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Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

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...

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...

This spring and summer, FDA revealed in several guidance documents what the agency thinks pharmacy compounding should look like now that the relevant provisions in federal law are firmly in place and the agency has a budget for oversight...Some of FDA's ideas, if incorporated into the final versions of the guidances, could be challenging for hospitals and health systems to implement…as hospitals continue to affiliate or form multihospital systems...a plan to centralize compounding activities may need to be reconsidered.

• Guidances, not regulations
• Limits on anticipatory compounding.
• Geographic limit on distribution.
• Address-dependent facility definition.
• No copycats of commercially available products.

Chinese drugs and pharmaceutical ingredients are found in medicine cabinets as far away as New York and Chicago, and the country’s exports of pharmaceutical products and health supplements worldwide jumped 3 percent to $56 billion last year...Yet even as China’s drug industry has grown in global stature, so have questions about the safety of its products...about 700 Chinese firms were told by regulators in China to review their pending applications to sell new drugs and voluntarily withdraw any that were false or incomplete. Within months, about 75 percent had been retracted by the manufacturers or rejected by Chinese officials...Among those were some medicines that were separately approved for sale in the U.S. by the Food and Drug Administration. Some of the companies say their data in China were flawed because of faulty information by local research firms...

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 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.

You can add Suffolk County, N.Y., to the list of local and state governments that are filing lawsuits against the drug makers that market opioid painkillers...The Long Island county...accused several companies — Purdue Pharma, Johnson & Johnson, and Endo International, among others — of using deceptive marketing to downplay the risks of their painkillers, and of improperly encouraging physicians to prescribe the medicines in a way that caused some patients to become addicts…The allegations are...identical to lawsuits filed by the city of Chicago; Orange and Santa Clara counties in California; and the state of Mississippi. In each case, the governments have charged the drug makers with illegally widening markets for their opioid painkillers and, as a result, forcing taxpayers to pay for medicines that were often prescribed unnecessarily...The companies "sought to create a false perception of the safety and efficacy of opioids in the minds of medical professionals and members of the public that would encourage the use of opioids for longer periods of time and to treat a wider range of problems, including such common aches and pains as lower back pain, arthritis, and headaches…

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...

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...