Members of the U.S. House and Senate have introduced bills that would allow Americans to import prescription drugs from Canada in an attempt to increase accessibility and lower the cost of drugs. Sens. Bernie Sanders (I-Vermont), Cory Booker (D-N.J.) and Bob Casey (D-Penn.) introduced the “Affordable and Safe Prescription Drug Importation Act” at the end […]
Policy
Facing pressure from pharma, FDA delays off-label promotion rule
After pharmaceutical industry groups filed a petition against the FDA’s new off-label promotion rule, the federal watchdog agency said last week it would delay the rule’s implementation to March 19, 2018. The agency originally intended for the law to go into effect on March 21 this year. The rule would expand the evidence that the […]
Under pricing pressure, insulin maker joins CVS Reduced Rx savings program
Facing pressure from lawmakers about the prices of their drugs, some pharmaceutical companies are looking for ways to make their products more affordable and more accessible. Novo Nordisk (NYSE:NVO) said yesterday that it is teaming up with CVS Health‘s (NYSE:CVS) new prescription savings program, Reduced Rx, to offer discounts on its insulin. The company’s insulin will be […]
Pharma stocks fall on Trump’s proposal to cut NIH budget
The Trump budget plan to slash more than 18% from the budget for the National Institutes of Health sent pharmaceutical stocks down today on Wall Street as investors reacted to the proposal. The budget proposal, released today, would cut the NIH budget by $5.8 billion, to $25.9 billion – an 18.3% cut. The proposal would also introduce […]
Senate confirms Verma to head CMS as debate intensifies over Obamacare replacement
The U.S. Senate voted yesterday 55-43 to confirm Seema Verma to head the Centers for Medicare and Medicaid Services. Verma is the founder & CEO of SVC Inc, a healthcare consulting firm, and worked with now-Vice President Mike Pence when he was governor of Indiana to redesign the state’s Medicaid program. Get the full story […]
Grassley questions Auvi-Q’s list price, while Trump shows support for Medicare drug-pricing reform
Although Mylan (NSDQ:MYL) has been under fire for its pricey EpiPen device since August last year, competitor Kaleo found itself garnering unwanted attention from politicians this week over the price of its epinephrine injection, Auvi-Q. Chairman of the Senate Judiciary Committee, Sen. Chuck Grassley (R-Iowa), wrote a letter to the Richmond, Virginia-based company asking CEO Spencer Williamson to explain […]
Study: Streamlined regulatory pathway has not shortened approval times for drugs
A study published by the Tufts Center for the Study of Drug Development found that the streamlined 505(b)(2) approval process for new drug applications in the U.S. has not led to shorter approval times. The 505(b)(2) pathway allows drug developers to seek FDA approval using safety and effectiveness data that was previously collected for a […]
Report: Boston Scientific’s U.S. hiring flat despite device tax pause
Boston Scientific (NYSE:BSX), a longtime vocal opponent of the medical device tax, has argued that the 2.3% tax would kill jobs in the industry. However, a report from the Boston Business Journal shows that the company’s U.S. headcount has remained constant over the past year. In its recent annual filing, the Marlboro-based firm said it ended the year […]
Trump calls for speedier approval process, while Sanders takes aim at drug prices
In his 1st address to Congress, President Donald Trump called for speeding up drug approvals within the FDA. Earlier that day, Sen. Bernie Sanders (I-Vermont) proposed a bill to allow the importation of prescription drugs from Canada in the hopes of lowering drug prices. The new administration has been critical of drug prices, with Trump saying that […]
CMS nominee Verma: Mylan’s EpiPen case ‘disturbing’
Seema Verma, the nominee to head the Centers for Medicare & Medicaid, said at her confirmation hearing that she would like to review the way pharmaceutical companies classify products as generic or branded, citing the case of Mylan‘s (NSDQ:MYL) EpiPen emergency allergy device. Mylan faced criticism this year for classifying EpiPen as a generic and paying smaller rebates to Medicaid […]
