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Pharmacy groups oppose the FDA’s new final rule that legalizes the importation of drugs from Canada. The rule was published late last week...The final rule implements a provision of federal law that allows FDA-authorized programs to import certain prescription drugs from Canada under specific conditions. According to the FDA, the rule allows states, Indian tribes, and – in certain future circumstances – pharmacists and wholesalers, to submit importation program proposals to the agency for review and authorization...the American Pharmacists Association criticized the agency’s rule...the new rule jeopardizes patient safety by creating supply chain vulnerabilities that could potentially introduce counterfeit or unsafe drugs...READ MORE

Results from a recent NCPA survey indicated that patients’ prescriptions are being transferred from independent pharmacies to chain stores without patients’ permission...Almost 80% of community pharmacists who responded to the survey said they’ve lost patients because of unfair “patient steering” in the past 6 months — and CVS Health is most often the culprit, NCPA said in the news release...“Many members have been telling us that their patients are being transferred to larger competitors, and in many cases the patients don’t know when, why, or how. This survey sheds some light on the problem, and the results are very disturbing,” said B. Douglas Hoey...READ MORE

U.S. President Donald Trump said...he may or may not approve any new, more stringent FDA standards for an emergency authorization of a COVID-19 vaccine, saying such a proposal would appear political...The Washington Post reported on Tuesday the U.S. Food and Drug Administration would issue the guidance to boost transparency and public trust as health experts have become increasingly concerned the Trump administration might be interfering in the approval process to rush out a vaccine...READ MORE

Any way you look at it, the numbers related to coronavirus vaccine candidates in development are impressive. In less than nine months, researchers have advanced 180 experimental coronavirus vaccines at least into preclinical testing. Thirty-five of those candidates are now in clinical studies...The field narrows considerably, though, when we look only at vaccine candidates that have made it to late-stage testing. Currently, only three experimental coronavirus vaccines are in phase 3 clinical trials being conducted in the U.S.:

-AstraZeneca
-Pfizer
-Moderna

Here's how these three coronavirus vaccines in phase 3 testing stack up against each other...READ MORE

When President Trump unveiled Operation Warp Speed in May, he declared that it was “unlike anything our country has seen since the Manhattan Project.”...Operation Warp Speed is largely an abstraction in Washington, with little known about who works there other than its top leaders, or how it operates. Even pharmaceutical companies hoping to offer help or partnerships have labored to figure out who to contact...Now, an organizational chart of the $10 billion initiative...reveals the fullest picture yet of Operation Warp Speed: a highly structured organization in which military personnel vastly outnumber civilian scientists...that many of the Warp Speed discussions take place in protected rooms used to discuss classified information...“This is a massive scientific and logistical undertaking,”...“We are weeks away, at most, a month or two away from having at least one safe and effective vaccine.”...READ MORE

Enabling tens of millions of Americans to get themselves speedily vaccinated against COVID-19 will be a huge logistics challenge. A new policy brief from the Mercatus Center, a think tank at George Mason University, argues that we could greatly accelerate the process by removing the complex state regulations that prevent pharmacists from administering vaccines...The...report recommends that state regulators relax age restrictions on pharmacist-administered vaccinations; issue statewide standing orders authorizing pharmacists to administer vaccines without requiring a physician-written prescription for each patient; and revise regulations, as Oregon has, to permit pharmacists to administer all of the vaccines recommended by the CDC's Advisory Committee on Immunization Practices. The latter recommendation "prevents lag in vaccine administration due to boards or legislatures having to approve individually named vaccines for pharmacist administration."...READ MORE

The US Food and Drug Administration... is expected to issue new, tougher requirements for its approval of a coronavirus vaccine, a move that could obliterate the chances of a shot getting emergency use authorization before Election Day...Regulators could publish the new approval standards as early as this week, and will do so publicly in an effort to bolster Americans' eroded trust in the US to ensure the safety a COVID-19 vaccine...President Trump and his Operation Warp Speed initiative have been pushing for months to have a coronavirus vaccine approved ahead of the November 3...READ MORE

Antibiotic resistance is one of the world's most urgent public health threats...Researchers at UC San Francisco are tackling antibiotic resistance using a different approach: redesigning existing antibiotic molecules to evade a bacterium's resistance mechanisms. By devising a set of molecular LEGO pieces that can be altered and joined together to form larger molecules, the researchers have created what they hope is the first of many "rebuilds" of drugs that had been shelved due to antibiotic resistance..."The aim is to revive classes of drugs that haven't been able to achieve their full potential, especially those already shown to be safe in humans,"..."If we can do that, it eliminates the need to continually come up with new classes of drugs that can outdo resistant bacteria. Redesigning existing drugs could be a vital tool in this effort."...READ MORE

President Donald Trump said that Americans in the Medicare program for the elderly and disabled will be sent $200 discount cards for prescription drugs within weeks, potentially putting cash in their pockets ahead of his November re-election...Assuming they are sent to 33 million Medicare beneficiaries, the figure Trump used, the cards would cost about $6.6 billion...Money for the cards will be drawn from a demonstration program Medicare uses to test new payment systems and other projects, and the cost will be offset by future savings generated from new price cuts Trump has ordered for drugs bought by Medicare, according to a White House official. The cards can be used for prescription drugs co-pays, the official said, but didn’t elaborate...READ MORE

Pharmacist remuneration models in ever-evolving healthcare settings must be examined if global health is to be supported...“A common concern among pharmacy associations worldwide is the long-term financial viability of professional services delivered by pharmacists. These concerns are first and foremost triggered by the impacts of continued price and margin cuts in dispensing of medicines and the non-allocation of funding in many settings for extended professional services and social care,”...“A successful remuneration model is one that promotes sustainable delivery of professional services. These should be integrated into broader health system strategies and, therefore, funding plans...READ MORE