Category:

• DEA Proposes New Regulations to Address Opioid Epidemic
• FDA Issues Report on Root Causes and Solutions to Drug Shortages
• HHS Announces Guide for Appropriate Tapering or Discontinuation of Long-Term Opioid Use
• FDA Releases Draft Best Practice Document for Postmarket Drug Surveillance
• FDA Issues Revised Draft Guidance on Regulation of Homeopathic Products, Withdraws 1988 Compliance Policy Guide
• DEA Warns of Increase in Scam Calls Targeting Pharmacists and Other DEA-Registered Providers

The Department of Health and Human Services has released a proposed rule this morning that proposes to lower the price of drugs for consumers by allowing pharmaceutical manufacturers to import certain prescription drugs from Canada...In addition, the Administration has announced the availability of a new draft guidance for the industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country...READ MORE

U.S. President Donald Trump said... he will soon release a plan to let Florida and other states import prescription medicines to combat high drug prices, and he blasted the Democrat-led House for not going far enough in a drug-pricing bill...“We will soon be putting more options on the table,” Trump wrote in a series of tweets, adding that House Speaker Nancy Pelosi “and her Do Nothing Democrats drug pricing bill doesn’t do the trick.”...Drug companies have staunchly opposed such a plan, which has been mulled for years but never implemented...READ MORE

Gov. Steve Sisolak last week took a small step toward dealing with Nevada’s rogue dental regulatory board. Let’s hope he doesn’t stop there...He should also consider a re-evaluation of all the state’s licensing boards, which too often function as protectionist entities more concerned with shielding existing interests than with promoting competition and public health and safety. The dental board is hardly the only problem...Last week, for instance, Gov. Sisolak revealed that the state Board of Pharmacy for more than a decade has often failed to conduct the required background checks of drug wholesalers. Last year, a report presented to the state executive audit committee cited numerous oversight issues with the more than three dozen occupational regulatory boards operating at the state level...READ MORE

A pharmacy group is taking a wait-and-see approach after California Governor Gavin Newsom announced several drug reforms–including a state generic prescription drug label...If the proposed reforms are approved, California would be the first state to have its own generic drug label...“A major cause of skyrocketing prescription drug prices is bargaining asymmetry, by which the pharmaceutical industry, often wielding monopoly power, is left unchecked, in the absence of a strong counterparty at the bargaining table…” Newsom said in the executive order...Although the California Pharmacists Association applauded the Governor’s “commitment to the healthcare of all Californians and ensuring all patients can continue to have access to affordable, life-saving medications," the organization said in a press release...CPhA declined to say whether it supports a state prescription drug label...READ MORE

“The announcement made today puts politics over patients. Eliminating the biologics provision in the USMCA removes vital protections for innovators while doing nothing to help U.S. patients afford their medicines or access future treatments and cures. The only winners today are foreign governments who want to steal American intellectual property (IP) and free ride on America’s global leadership in biopharmaceutical research and development...“We cannot support abandoning provisions that protect American companies and raise standards abroad. We hope that Congress and the Administration will pursue international trade agreements that hold foreign governments accountable by ensuring that they protect and value the ongoing discovery of much-needed medicines to treat and potentially cure the world’s most devastating diseases.”...READ MORE

The U.S. government is barring federal dollars meant for opioid addiction treatment to be used on medical marijuana...The move is aimed at states that allow marijuana for medical uses, particularly those letting patients with opioid addiction use pot as a treatment, said Dr. Elinore McCance-Katz, whose federal agency doles out money to states for treatment programs...“There’s zero evidence for that,” McCance-Katz said. “We felt that it was time to make it clear we did not want individuals receiving funds for treatment services to be exposed to marijuana and somehow given the impression that it’s a treatment.”...READ MORE

Israeli ministers on Thursday averted a health care crisis by passing a last-minute allocation of 500 million shekels ($143 million) to pay for new lifesaving medicines for thousands of patients...Israel is without a permanent government and has no state budget for 2020, meaning its ministries by law revert to the previous year’s budget with no new spending...Thousands of patients suffering from all sorts of diseases feared this meant no money to cover new drugs or medical technologies that they hope will save or improve their lives...READ MORE

With the major Democratic 2020 candidates campaigning on lowering drug prices, march-in rights are now back in focus as a tool to achieve that goal. Biopharmas are setting too-high prices for drugs discovered with taxpayer support, the argument goes, which ought to spur the government to take possession of their patents to lower costs. The Trump administration also has shown some interest in pharma patents...The calls are only growing thanks to "patent thickets," the expansive intellectual property estates that drugmakers use to shield drugs from generic competition well beyond the date of first patent expiration...The problem with appealing to march-in rights as a solution is the government has always refused to use the power it holds...READ MORE

The Trump administration estimates it will release rules on drug prices and information blocking this month but punted finalizing a rule on interoperability until as late as 2022..The White House Office of Management and Budget released...the unified regulatory agenda for fall 2019...The agenda said that a major rule that would outlaw information blocking among providers is estimated to be released this month...The unified agenda also gives an update on key regulations addressing high drug prices...One such proposal is a demonstration model that would tie the price of physician-administered drugs paid by Medicare Part B to an index made up of cheaper prices paid by other countries...The agenda also provides an estimated release date of January 2020 for a proposed rule to allow the importation of drugs from Canada. The proposed rule would create a pilot project to allow states, wholesalers and pharmacists to import drugs from Canada at a cheaper price than in the U.S...READ MORE