- Trump signs executive order to boost U.S. drug manufacturing (reuters.com)
President Donald Trump...signed an executive order aimed at boosting U.S. production of medicines and medical equipment, lowering drug prices and protecting the United States against shortfalls in a future pandemic...Trump said the order would also support advanced manufacturing processes that would benefit U.S. pharmaceutical companies...The long-awaited measure includes a “Buy America” provision mandating federal purchases of certain medical supplies and equipment deemed essential and moves to remove regulatory hurdles to approval of new U.S. drugs...READ MORE
- Trump administration unveils executive orders to curb drug prices — but they come with caveats (statnews.com)Trump signs limited drug pricing orders after last-minute debate (politico.com)PhRMA Statement on Drug Pricing Executive Orders (phrma.org)President Trump Signs 4 Drug Pricing Executive Orders (healthleadersmedia.com)
The Trump administration unveiled four executive orders on Friday aimed at bringing down pharmaceutical prices...1) he (Trump) announced a one-month ultimatum for drug manufacturers to propose alternative plans to reduce drug prices...“We’re going to hold that until August 24, hoping that the pharmaceutical companies will come up with something that will substantially reduce drug prices,” Trump said...2) A second order...revives a...plan that would eliminate the rebates drug makers pay to insurers...The executive order...includes a caveat that the plan cannot be implemented if it will raise premiums...3)...the Trump administration is expanding its efforts to allow Americans to import medicines...the administration was now allowing personal importation, a phrase used to describe when individual consumers buy drugs from other countries...The order says HHS will facilitate “grants to individuals of waivers of the prohibition of importation of prescription drugs.”...4) The fourth order would force certain health centers to pass negotiated discounts on insulin and EpiPens to patients...READ MORE
- Major health groups raise alarm over U.S. departure from World Health Organization (fiercehealthcare.com)
Major health groups raised alarm following the announcement Friday by President Donald Trump that the U.S. is terminating its relationship with the World Health Organization...Trump previously said he would cut funding to WHO, a United Nations agency that helps promote global health initiatives including addressing disease outbreaks. He said WHO has not pushed for accountability over its handling of the virus that is believed to have originated in Wuhan, China. He has also previously said WHO was slow to act in response to the COVID-19 pandemic...But organizations such as the American Medical Association and the Infectious Diseases Society of America condemned the move, saying it will make the work of fighting the global pandemic "dramatically more challenging."...READ MORE
- Sisolak signs restriction order for 2 drugs (reviewjournal.com)Emergency regulation on prescribing and dispensing chloroquine and hydroxychloroquine during COVID 19 pandemic (bop.nv.gov)UPDATE: Gov. Sisolak tries to prevent 'drug hoarding' in new emergency regulation (ktnv.com)Nevada Governor Bars Gatherings of More Than 10 People (usnews.com)
Gov. Steve Sisolak has signed an emergency measure to safeguard the threatened supply of two drugs being hoarded for possible use in the treatment of COVID-19...The governor signed the emergency regulation Tuesday on the recommendation of the state Board of Pharmacy...The drugs, chloroquine and hydroxychloroquine, are used to treat malaria, lupus and rheumatoid arthritis and are being studied by the Food and Drug Administration for possible use in patients with mild-to-moderate COVID-19...The governor’s order prohibits the prescribing and dispensing chloroquine and hydroxychloroquine for a COVID-19 diagnosis, requires the appropriate prescription coding for their “legitimate medical purposes” and limits prescriptions to a 30-day supply...The order doesn’t limit use of the drugs in hospitals, only in outpatient settings where hoarding is evident, the governor’s office stressed. Doctors may continue to prescribe them to hospitalized COVID-19 patients at their discretion...READ MORE
- Telemedicine is booming — but many people still face huge barriers to virtual care (statnews.com)Telehealth seems here to stay – so how can it be improved? (healthcareitnews.com)
As Covid-19 drives many patients away from in-person care and toward virtual visits, experts warn that the nation’s most vulnerable members may be shut out of the booming telehealth business...Federal policymakers temporarily relaxed regulations to make it easier to provide virtual care during the pandemic, fueling a shift toward telemedicine that has become so popular among patients and providers that there are now a number of proposals to make the changes permanent. Just this week, President Trump signed an executive order that would permanently extend some of those policies...But a pair of new studies published this week show that there are barriers to virtual visits that regulatory changes alone can’t fix...READ MORE
- As U.S. calls for stateside manufacturing, antibiotic maker Paratek gambles on ‘onshoring’ effort (fiercepharma.com)
...the U.S. government has shelled out big money for a stable and reliable supply of key drugs made on U.S. soil. For drugmakers accustomed to offshore manufacturing in cheaper countries, does it make any sense to onshore production to meet U.S. demand?...One company has a compelling argument, and it's taking big risks—and government funding—to test its hypothesis...Paratek Pharmaceuticals, maker of antibiotic Nuzyra, is kick-starting a three-year plan to build a government-funded, second supply chain in the U.S. in an effort to flesh out the nation's strategic supply of pandemic response drugs...The U.S. government, through its Biomedical Advanced Research and Development Authority, has dumped more than $300 million combined into helping Paratek build the U.S. supply line, which will stand apart from its current manufacturing network in Europe...READ MORE
- CMS Lowers Medicare Insulin Copays (drugtopics.com)Out-of-Pocket Insulin Costs Remain Stable for the Privately Insured (ajmc.com)
The Centers for Medicare & Medicaid Services is reducing insulin copays for seniors who are eligible for Medicare via an executive order from President Donald Trump...Participating enhanced Medicare Part D plans in 2021 will provide a broad set of insulins at a maximum $35 copay for a month’s supply of each type of insulin, the White House said in a fact sheet on the new initiative...CMS estimates that beneficiaries could save $446, or 66%, a year for their insulins, the agency said in a press release...READ MORE
- Trump wants broader role for telehealth services in Medicare (apnews.com)
The Trump administration is taking steps to give telehealth a broader role under Medicare, with an executive order that serves as a call for Congress to make doctor visits via personal technology a permanent fixture of the program...The order President Donald Trump signed...applies to one segment of Medicare recipients — people living in rural communities. But administration officials said it’s intended as a signal to Congress that Trump is ready to back significant legislation that would permanently open up telehealth as an option for all people with Medicare...READ MORE
- U.S. seeks to ‘onshore’ drug production in response to COVID-19. Is pharma even interested? (fiercepharma.com)
With the COVID-19 pandemic shining a spotlight on the global pharmaceutical supply chain, U.S. legislators have put forward a raft of legislation that would seek to "onshore" drug manufacturing at the expense of major producers abroad...Guess who's wary of that proposal? Big Pharma...the White House is reportedly working on a "Buy American" executive order that would require government agencies to purchase American-made medical products, and that order could eventually include pharmaceuticals...the Pharmaceutical Research and Manufacturers of America...has pushed back against Congressional support for a supply chain shake-up...Manufacturing stateside would likely cost a princely sum compared with the cheaper wages and lower costs abroad, and would upset the balance of pharma's global supply chain..."While we support efforts to foster more manufacturing in the United States, moving all manufacturing here is impractical and likely not feasible," a PhRMA spokesperson said in an email. "Policymakers must take a long-term, more holistic look at global pharmaceutical manufacturing supply chains before jumping to rash proposals that may cause significant disruptions to the U.S. supply of medicines."...READ MORE
- Trump cutting U.S. ties with World Health Organization over virus (reuters.com)
The United States will end its relationship with the World Health Organization over the body’s handling of the coronavirus pandemic, U.S. President Donald Trump said on Friday, accusing the U.N. agency of becoming a puppet of China...The move to quit the Geneva-based body, which the United States formally joined in 1948, comes amid growing tensions between Washington and Beijing over the coronavirus outbreak...Speaking in the White House Rose Garden, Trump said Chinese officials “ignored their reporting obligations” to the WHO about the virus - that has killed hundreds of thousands of people globally - and pressured the agency to “mislead the world.”...READ MORE