The U.S. False Claims Act has been the subject of a substantial body of jurisprudence and policymaking, but the legal terrain has not necessarily grown any more predictable for makers of drugs and medical devices. A new update on FCA prosecutions by the law firm of Gibson Dunn highlights the fluidity of considerations such as the materiality of an allegation of a false claim despite a Supreme Court decision in 2016 (Universal Health Services, Inc. v. United States ex rel. Escobar) that was expected to provide a more stable interpretation of the law, just one example of a legal landscape that still creates substantial uncertainty for companies in the life sciences.

Growing sales of its multiple sclerosis (MS) therapies and lower R&D expenses led Biogen Inc. to beat both top- and bottom-line expectations during the second quarter, despite lower-than-expected sales of its spinal muscular atrophy (SMA) drug, Spinraza (nusinersen).

Amid all the bills aimed at shining light into the black box of U.S. drug pricing and ending anticompetitive games, the House is planning on rolling out legislation in September that would directly impact the price of what could be hundreds of drugs by requiring Health and Human Services (HHS) to negotiate some prices.

The best way to score political points is to actually do something about U.S. prescription drug prices. That's the message members of the New Democrat Coalition Health Care Task Force delivered Wednesday to their party leadership in the House, as they requested another vote next week on a package of bipartisan drug pricing bills – this time minus the partisan provisions that Democrats knew would never fly in a Republican-controlled Senate.

Perhaps the hardest hit by the unintended consequences of well-intentioned legislation, U.S. insulin products continue to be the congressional poster child of all that's wrong with drug prices in America.

In the largest U.S. opioid-related settlement yet, Reckitt Benckiser Group plc agreed to pay a total of $1.4 billion to end federal civil and criminal investigations into its role in delaying generic competition to Suboxone, an opioid-addiction treatment drug.

Faced with a tradeoff between low Medicare premiums that benefit all beneficiaries and lower out-of-pocket costs that benefit the sickest beneficiaries, the Trump administration chose lower premiums, sinking a proposed rule that would have pulled drug rebates from the safe antikickback harbor.

The U.S. Court of Appeals for the Federal Circuit this week sidestepped some of the concerns raised by the biopharma industry, choosing instead to simply vacate and remand two Patent Trial and Appeal Board's (PTAB) decisions that invalidated patent claims involving the securing of communications over the Internet.

The striking of a Health and Human Services (HHS) rule requiring TV ads for prescription drugs to include list prices may turn up the temperature on the political roasting of biopharma companies – and stoke the pressure for Congress to do something about those prices.

With regulatory science always lagging innovation, ambiguity has long been a certainty at the FDA and is likely to become even more so as the pace of new technologies quickens.