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Unfortunately, there are a lot of assertions floating around that tell a misleading story about pharmaceutical manufacturing, diminishing America’s leadership and suggesting our reliance on other countries has put us at risk of potential shortages. In reality...the biopharmaceutical industry supports more than 4 million jobs across the United States, directly employing more than 811,000 Americans. Of those jobs, nearly 120,000 are high-wage manufacturing jobs, which is double the percentage of manufacturing jobs compared to the private sector overall...Discussions about enabling more manufacturing in the United States are important, but let’s not forget that the United States already sustains a substantial manufacturing presence that is part of a larger global network. We cannot replace all global manufacturing with solely U.S. manufacturing without upsetting the entire biopharmaceutical supply chain to the detriment of patients...READ MORE

Not wanting to be left behind in the COVID-19 vaccine race, Europe is stepping up its efforts to secure supplies should any immunizations prove safe and effective. Right on the heels of news that the U.S. has picked vaccine finalists to fast-track, Europe is considering negotiations with pharmaceutical companies for early acces..The European Union has asked member countries for the power to negotiate development and access deals with drugmakers.. if the mandate were approved, Europe would base its program on the U.S.’ Biomedical Advanced Research and Development Authority...READ MORE

The U.S. government...entered into a $628 million contract with drugmaker Emergent BioSolutions to boost manufacturing capacity for a potential COVID-19 vaccine...As drugmakers capacity here in America for candidates that make it to the final stages of Operation Warp Speed will help get a vaccine to American patients without a day wasted,” Department of Health and Human Services Secretary Alex Azar said in a statement...The HHS task order with Emergent falls under an existing contract with the Biomedical Advanced Research and Development Authority...Under the contract, Emergent will commit its manufacturing facilities, valued at $542.7 million, to produce COVID-19 vaccine candidates through 2021...READ MORE

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

...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

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

The COVID-19 pandemic has underscored key weaknesses in the biopharma industry’s complex global supply chain, and now a top adviser for the Trump administration is calling on Congress to push for more manufacturing in Puerto Rico...White House trade adviser Peter Navarro faulted a “broken system” that pushes manufacturing offshore. He called on Congress to use the next round of COVID-19 relief to incentivize manufacturing on the island territory...Previously, a tax provision allowed U.S. companies to avoid paying federal taxes on profits from operations in Puerto Rico, but Congress phased that out over time...Plus, utility costs are significantly higher there than in the U.S., which has also led to a reduction in manufacturing. Pharma companies themselves have shuttered a number of drug plants in Puerto Rico in recent years...READ MORE

The U.S. biopharmaceutical industry depends on reliable intellectual property protections to promote the development of new treatments and cures for patients. Strong IP protections are especially important as innovators work around the clock making substantial investments at risk to develop solutions to help prevent infection and treat those with COVID-19...many of the existing medicines and investigational medicines in clinical trials for COVID-19 exist today because of IP and other incentives that drove their initial research...Strong and reliable IP protections support America’s robust innovation ecosystem by promoting innovation and affordability for patients who rely on new treatments and cures...READ MORE

The Canada Revenue Agency is opening up its snitch line to tips about fraud in COVID-19 federal aid programs amid reports of illicit applications and double dipping...Canada Revenue Agency says its National Leads Program — a.k.a. its snitch line — is now accepting information regarding the Canada Emergency Response Benefit (CERB), the Canada Emergency Student Benefit (CESB), and the Canada Emergency Wage Subsidy (CEWS)...“If you suspect a potential misuse of the COVID-19 emergency benefits and programs, the National Leads Centre is currently accepting leads on these programs,”...the agency says it’s looking for information regarding people who are receiving either CERB or CESB who are ineligible, or businesses or charities that are “misusing” the wage subsidy program...READ MORE

Canada’s patented drug regulator is delaying the implementation of new pricing guidelines until 2021, to make “significant changes” in response to feedback it received during public consultations...Changes to the patented medicines regulations, which were originally announced last year, were supposed to go into force on July 1, 2020...The delay was applauded by federal opposition Conservatives, who argued that the regulatory changes set aggressive price ceilings for some new therapies — particularly for rare disorders — that would all but ensure they would not be brought to the Canadian market...“I’m relieved that the voices of patients have been heard and the government has decided to delay the changes. However, we still have a lot of uncertainty and I expect the government to use this additional time to better consult with patients,” Conservative MP and party health critic Matt Jeneroux said in a statement...We could see a drug shortage if these changes go ahead as planned in six months. Canada will no longer be a competitive marketplace and drug companies will be reluctant to bring their therapies here...READ MORE