The Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the U.S. District Court for the Eastern District of California challenging SB 17, which California passed in October in what state lawmakers proclaimed as the first step in saying no to high drug prices across the nation. PhRMA claims the state law is unconstitutional because it attempts to dictate national health care policy on drug prices. SB 17 requires manufacturers to provide a 60-day notice before raising prices of certain drugs more than 16 percent over a two-year period, along with an explanation for the increase. In so doing, it singles out drug manufacturers as the sole determinant of drug costs despite the role other entities play in the costs patients pay, PhRMA said, and it will cause market distortions such as drug stockpiling and reduced competition.

The FDA is taking more steps to protect consumers from false or misleading drug ads. The agency finalized its 2013 revised draft guidance on product name placement, size, prominence and frequency in promotional labeling and advertisements. It also is proposing two studies to provide data on whether consumers and health care professionals can identify promotional claims as false or misleading and whether they would be willing to report deceptive drug promotion to the FDA, according to a notice in the Federal Register. One study will focus on the degree of deception in an ad, while the second one will focus on implied vs. explicitly deceptive claims.

U.S. Sen. Elizabeth Warren (D-Mass.) has introduced the National Biomedical Research Act to develop a new funding stream for targeted biomedical research at the FDA and NIH. The bill, which Warren discussed at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Thursday, is intended to help restore the NIH budget to its 2006 levels. The legislation would create the Biomedical Innovation Fund to provide predictable investments in biomedical research conducted by leading scientists at the nation's top research institutions, according to Warren. It also would provide $5 billion annually in supplemental funding for grants for young emerging scientists and breakthrough research.

"Get your act together or else ..." was the message Republican and Democrat alike delivered last Wednesday to drug companies, insurers and pharmacy benefit managers (PBMs) during a House subcommittee hearing on the prescription drug supply chain and its impact on drug prices. "I hope the message is getting through that, on a bipartisan basis, we're kind of reaching the end of our tether" on drug pricing, Rep. John Sarbanes (D-Md.) said as he warned witnesses from the various industries involved in the supply chain that if they don't address the problem, Congress may go in a direction they won't like. One possibility would be to treat drugs like a utility, he said.