Category:

...groups lobbying for lower prescription drug prices called on Congress to enact long-awaited reforms and stressed the urgency of the movement...Answering the call...the Senate Judiciary Committee, which voted unanimously to advance four pieces of legislation which would help rein in the cost of prescription drugs...The new laws take particular aim at the tactics used by drug companies to extend patent protections and stifle competition from cheaper generic and biosimilar drugs. The legislation, which would enhance the Federal Trade Commission's ability to initiate enforcement actions against drug companies, now moves to the Senate floor for a vote...READ MORE

• Practice Guidelines for the Administration of Buprenorphine for Treating OUD
• Resumption of In-person Inspections
• New Law CE
• Inspector RetiredPharmacy Inspector
  Joe “Batman” Depczynski
• New Board Investigator/Inspector
  Monica S. Segedy
  Mui Lee, RPh,

Britain's competition regulator has fined more than 10 drug firms a record combined 260 million pounds ($360 million) for overcharging the National Health Service for a steroid which rose from 70p to 88 pounds a pack in under eight years...The Competition and Markets Authority said...that the breaches meant the NHS paid over 10,000% more for single packs of 10 mg and 20 mg hydrocortisone tablets in 2016 than they were paying in 2008...The CMA said companies including Actavis, and its former parent and now Abbvie-owned Allergan, broke competition rules...READ MORE

The Food and Drug Administration is preparing to announce a new warning for the Johnson & Johnson coronavirus vaccine saying the shot has been linked to a serious but rare side effect called Guillain-Barré syndrome, in which the immune system attacks the nerves...About 100 preliminary reports of Guillain-Barré have been detected after the administration of 12.8 million doses of Johnson & Johnson vaccine in the United States, the Centers for Disease Control and Prevention said in a statement Monday. The cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 and older...READ MORE

The U.S. Securities and Exchange Commission has halted registrations of U.S. initial public offerings by Chinese companies...The U.S. is saying that it is waiting for the Chinese government to disclose to investors the risks to investment with the Chinese government interfering in the businesses. The Chinese government has, according to Reuters, been reluctant “to submit to U.S. auditing standards and improve the governance of companies held closely by founders.”...READ MORE

Pfizer has issued a voluntarily recall for 12 lots of its anti-smoking drug Chantix (varenicline) due to the presence of a nitrosamine impurity exceeding the company’s established Acceptable Daily Intake level. As a result, the company is pausing distribution of Chantix and is accelerating its internal testing of the drug...The FDA stated N-Nitroso-varenicline is found within the nitrosamine class of compounds, and some of these compounds are either possible or probable carcinogens. “Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” the FDA said...READ MORE

Drug-overdose deaths in the U.S. surged nearly 30% in 2020, the tragic result of a deadlier supply and the destabilizing effects of the Covid-19 pandemic, according to preliminary federal data and public health officials...The estimated 93,331 deaths from drug overdoses last year, a record high, represent the sharpest annual increase in at least three decades, and compare with an estimated toll of 72,151 deaths in 2019, according to provisional overdose-drug data released...by the Centers for Disease Control and Prevention...READ MORE

The American Civil Liberties Union of Nevada and the Nevada Press Association have filed a federal lawsuit calling for a halt to the state’s planned execution of Zane Floyd – which would be the state’s first in 15 years — unless the process is more transparent...The lawsuit...argues that the state violates the First Amendment by interfering with the media’s ability to observe Zane Floyd’s execution in its entirety and without obstruction. The lack of transparency is especially concerning given that the state is “using experimental drug cocktails and an untested facility,”...READ MORE

The Association for Accessible Medicines’ latest report found that Medicare Part D plans are slow to add new generics to their formularies and often place them on nongeneric pricing tiers...Medicare Part D plans are slower than commercial plans to adopt new generics, and even when adopted, the generics are less likely to be part of a generic cost tier. That’s according to a new report from the Association for Accessible Medicines that examines the speed of first generics entering formulary coverage for both Medicare Part D plans and commercial plans...READ MORE

Although Martin Shkreli has been behind bars for years due to a conviction for investment fraud, the man known as “Pharma Bro” has remained active running the former Turing Pharmaceuticals from his jail cell. However, that could change if some activist investors...have their way...Turing is the company that gained infamy after acquiring the decades-old toxoplasmosis drug Daraprim and raising the price by 5,000%. When Shkreli’s Turing Pharmaceuticals acquired Daraprim, the cost of a single pill was about $13.50. Turing increased the price to $750 per tablet, which drastically raises the cost of treatment for patients...READ MORE