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Walgreens is increasing the age to buy tobacco at its drugstores to 21 later this year as the retailer faces possible sanctions from the Food and Drug Administration for allegedly selling to minors...The FDA put Walgreens “on notice” in February, accusing the pharmacy chain of violating rules that prohibit selling cigarettes and other tobacco products to underage buyers. Walgreens, the FDA noted, is currently the top violator among pharmacies that sell tobacco products. Some 22 percent of Walgreens locations inspected by the agency caught employees illegally selling tobacco products to minors...READ MORE

The MD Anderson Cancer Center said it decided to fire three scientists who, among other allegations, failed to disclose international collaborators. Two of them resigned...in connection with an investigation into possible foreign attempts to take advantage of its federally funded research...Federal officials said they found that some researchers had shared with Beijing intellectual property and pilfered confidential information from grant applications. Other researchers had failed to disclose that they were receiving money from foreign sources while being funded by the N.I.H...Federal officials have said that some scientists have run “shadow laboratories” in China while conducting N.I.H.-funded research in the United States. This month, the N.I.H. said 55 institutions across the country are investigating such concerns...READ MORE

The founder of Insys Therapeutics Inc put profits over patients’ safety by bribing doctors to prescribe an addictive fentanyl spray, fueling the U.S. opioid epidemic, a federal prosecutor said...at the end of a landmark trial...John Kapoor, who served as the drugmaker’s chairman, and four colleagues are the first executives of a painkiller manufacturer to face trial for conduct that authorities say was tied to a drug abuse epidemic that kills tens of thousands of Americans each year...He (Assistant U.S. Attorney Nathaniel Yeager) said Kapoor also sought to defraud insurers into paying for Subsys and carried out the scheme with the help of his co-defendants, former Insys executives and managers Michael Gurry, Richard Simon, Sunrise Lee and Joseph Rowan...All five have pleaded not guilty to racketeering conspiracy...READ MORE

Pfizer Inc said...it received a request for documents as part of a U.S. investigation related to quality issues involving the manufacture of auto-injectors at its Meridian Medical Technologies site...Meridian, a unit of Pfizer that manufactures EpiPen injectors...has been hit by a series of manufacturing problems in recent years...In 2017, Meridian had received a warning letter from the Food and Drug Administration. The FDA said Meridian had failed to thoroughly investigate product failures, including EpiPen products that were associated with patient deaths and severe illnesses. It said the company failed to take corrective actions until FDA’s inspection...

Federal prosecutors charged drug distributor Rochester Drug Cooperative and its former CEO with drug trafficking charges...the first criminal charges for a pharmaceutical company and executives in the nation's ongoing opioid crisis... This prosecution is the first of its kind: executives of a pharmaceutical distributor and the distributor itself have been charged with drug trafficking...The U.S. Attorney's Office for the Southern District of New York charged Rochester Drug Cooperative...with "knowingly and intentionally" violating federal narcotics laws "by distributing dangerous, highly addictive opioids to pharmacy customers that it knew were being sold and used illicitly,"...RDC was also charged with failing to properly report thousands of suspicious orders of oxycodone, fentanyl and other controlled substances to the Drug Enforcement Agency...READ MORE

The people charged across 11 federal districts, include 31 doctors, seven pharmacists, eight nurse practitioners, and seven other licensed medical professionals...The cases involve more than 350,000 prescriptions for controlled substances across Ohio, Kentucky, Tennessee, Alabama, and West Virginia...The Justice Department said six individuals, including two doctors and three registered pharmacists were charged with several counts, including unlawful distribution of controlled substances and conspiracy to obtain controlled substances by fraud...One arrest...involved a doctor in Kentucky who allegedly prescribed opioids to friends on Facebook, who would then come to his home to pick up prescriptions...Another case involved a doctor in Tennessee who branded himself the “Rock Doc.” He allegedly prescribed combinations of dangerous combinations of opioids and benzodiazepines, a class of psychoactive drugs, sometimes in exchange for sexual favors...READ MORE

The U.S. Bureau of Prisons said...it was investigating former drug company executive Martin Shkreli's conduct in prison after the Wall Street Journal reported he was still helping run his old company using a contraband cellphone..."When there are allegations of misconduct, they are thoroughly investigated and appropriate action is taken if such allegations are proven true," the Bureau of Prisons said in a statement. "This allegation is currently under investigation."...READ MORE

In its latest move to rein in what it views as anticompetitive tactics in the healthcare industry, the Federal Trade Commission filed a lawsuit against health information company Surescripts charging the company with illegally monopolizing the e-prescribing market...The FTC alleges that the company employed "illegal vertical and horizontal restraints in order to maintain its monopolies over two e-prescribing markets: routing and eligibility."... Surescripts has maintained at least a 95% share over many years...the FTC said it is seeking to undo and prevent Surescripts’s unfair methods of competition, restore competition, and provide monetary redress to consumers...READ MORE

Three drugmakers will pay $122.6 million to resolve claims they used charities that help cover Medicare patients’ out-of-pocket drug costs as a way to pay kickbacks aimed at encouraging use of their medications, including some expensive ones...The U.S. Justice Department...said Jazz Pharmaceuticals Plc, Lundbeck A/S and Alexion Pharmaceuticals Inc had become the latest companies to settle claims stemming from an industry-wide probe of drugmakers’ financial support of patient assistance charities...The government has alleged in earlier settlements that drugmakers used such charities as a means to improperly pay the copay obligations of Medicare patients using their drugs in violation of the Anti-Kickback Statute...READ MORE

The US Food and Drug Administration has sent a warning letter to Canadian drug distributor CanaRx following an investigation, which found the company has been facilitating the distribution of unapproved and misbranded drugs to US consumers...The letter called on CanaRx to...cease distributing these products in the US and stated failure to do so could result in further regulatory action...CanaRx’s distribution scheme involves foreign physicians re-writing the prescriptions of employees of public and private organisations, which have signed up to this programme, and then supplying the patient with unapproved generic versions of FDA-approved drugs...The issue is that employees are likely to assume they are getting safe, approved medicines through their employer’s insurance plan, when in fact they may not be...READ MORE