Pre-Term Birth Drug Calls Into Question FDA’s Prolific Use Of Expedited Approval Process

Bloomberg: The Problem With The FDA’s Quick-Approval Process For Drugs
One in 10 babies in the U.S. is born premature, with elevated rates of disability and death. For almost a decade, a drug called Makena has been used to reduce the risk of further instances of early delivery for women who’ve previously given birth prematurely. The medicine, approved in 2011 under the Food and Drug Administration’s accelerated process, contributed more than $300 million of annual sales for its manufacturer, Amag Pharmaceuticals Inc. New research calling into question how well the drug works is now prompting the FDA to consider delisting Makena—a rare step for an approved treatment. (Court, 3/27)

Stat: Biosimilars Could Disappear If The Supreme Court Overturns The ACA 
With the sense of urgency rightly focused on slowing or stopping the spread of Covid-19, it seems like everything else in the news, and in health care, has come to a grinding halt. Yet important decision-making continues in the background, including some that could have long-lasting effects on health care today and in the future. One of these is the decision by the U.S. Supreme Court to hear California v. Texas, a case that will decide whether most or all of the Affordable Care Act should be overturned. (Lynch, 1/1)

Stat: Capitol Hill’s Coronavirus Response Delays Drug Pricing Legislation
Before the coronavirus pandemic became Congress’ sole focus, late May was widely viewed as a final 2020 deadline for lawmakers to take action on key health policy issues, including legislation to lower the price of prescription drugs. But with the Covid-19 crisis dominating every aspect of American politics, such legislation will have to wait. A recent $2 trillion relief package that lawmakers passed on Friday could mean drug pricing advocates might be waiting a long while — likely until November, weeks after Election Day. (Facher, 3/30)

Modern Healthcare: FDA Warns Of EpiPen Device Malfunctions
The EpiPen and EpiPen Jr. devices, which are commonly used to treat emergency allergic reactions, may have delayed injections or fail to inject properly due to design issues or improper administration by users, the U.S. Food and Drug Administration alert said. The agency was made aware of the issues through a letter Mylan recently sent to healthcare workers warning of the problems. Mylan was recently acquired by drug maker Pfizer but continues to use its name. (Castellucci, 3/24)

FiercePharma: Lilly Ad Campaign In U.S. Newspapers Offers Diabetes Med Help For Patients Affected By COVID-19 Shutdowns
Eli Lilly wants diabetes patients who use its drugs to know that help is available, and to get the word out, it bought full-page ads in more than a dozen newspapers in the U.S. The simple print ads, which ran Monday, spoke directly to people who recently lost jobs or health insurance and told them to contact the Lilly Diabetes Solution Center for help. Driven by COVID-19 shutdowns and job losses in the millions, Lilly had already seen a 32% increase in call volumes to the diabetes help call center. After the ads ran Monday, call volume jumped by 91% over the previous Monday, March 23. The 340 incoming calls marked the highest single-day call volume since the program began in August 2018. (Bulik, 3/31)

Stat: A Sickle Cell Doctor Tracks Dollars, Disparities, And Drug Development 
Sickle cell disease and cystic fibrosis are both rare, genetic diseases. While there are three times as many people (predominantly of African ancestry) in the U.S. with sickle cell disease compared to people (predominantly of European ancestry) with cystic fibrosis, research dollars are the same, after tallying federal funding from the National Institutes of Health and disease-specific foundations. That per-patient funding gap has been known for decades. (Cooney, 3/31)

Reuters: U.S. Court Rules For Teva In Migraine Patent Dispute With Eli Lilly
The Patent Trial and Appeal Board (PTAB) upheld the validity of three Teva patents on its migraine treatment Ajovy, rejecting arguments by Eli Lilly that they were invalid. Teva Pharmaceutical Industries Ltd on Tuesday won a ruling from a U.S. administrative court that could help it fend off competition from Eli Lilly and Co in the market for migraine drugs. (Wolfe, 3/31)

Stat: FDA Closes Review Of Novartis Data Integrity Scandal With No Penalty
An embarrassing scandal that Novartis (NVS) endured over data integrity has quietly come to a close, with the Food and Drug Administration instructing the drug maker to correct the problem at its AveXis unit, but without imposing any penalties. At issue was a delay in the disclosing to the agency that manipulated data existed for its Zolgensma gene therapy. Novartis became aware of the problem in March 2019, but did not inform the FDA until after the drug was approved last May. Zolgensma, which costs $2.1 million, is used to treat a type of spinal muscular atrophy and was developed by AveXis, which Novartis bought in April 2018. (Silverman, 3/31)

FiercePharma: FDA Lets Novartis Off The Hook In Zolgensma Data Manipulation
When Novartis’ Zolgensma data manipulation problem first went public last August, an angry FDA said it would consider civil or criminal penalties. But it looks like neither of those is going to happen. In a statement shared with FiercePharma, an FDA spokesperson said the agency has decided it will not punish Novartis’ gene therapy unit AveXis for doctoring Zolgensma mice testing data in its drug application package. The news was first reported by Biopharma Dive. (Liu, 3/31)

FiercePharma: Mylan, Pfizer Offer Undisclosed Concessions As Part Of EU Merger Review
Amid operations concerns over the novel coronavirus pandemic, Mylan and Pfizer's Upjohn unit have already postponed the close of their pending generics megamerger. Now, in order to clear antitrust hurdles in Europe, the drugmakers have agreed to meet regulators in the middle. Mylan and Upjohn have agreed to concessions as part of the European Commission's antitrust review of their pending merger, according to a commission filing. While the EU did not disclose just what those concessions are, the sale of competing assets in merging drugmakers' portfolios is often a sticking point for antitrust legislators. (Blankenship, 3/31)

Stat: Chinese Regulator Scolds A U.S. Company For Drug-Manufacturing Problems
The shoe is on the other foot, so to speak.For the past few years, the Food and Drug Administration has tried harder to scrutinize Chinese pharmaceutical suppliers over widespread quality control concerns. Now, though, a Chinese government agency has found problems with a U.S. company that does contract manufacturing work for Bristol Myers Squibb (BMY) and, as a result, shipment of a key product to China has been suspended. (Silverman, 3/25)