What We're Reading: Drug Pricing Measures; Gun Violence Research; Postmarketing Safety Reporting

March 22, 2018

Congress reached an agreement on a $1.3 trillion spending bill that includes a provision allowing gun violence research, but does not include 2 drug pricing measures or a provision to stabilize the Affordable Care Act markets; and FDA has released 2 draft guidances on postmarketing safety reporting requirements.

Spending Bill Missing 2 Drug Pricing Measures

Congress reached an agreement for a $1.3 trillion federal spending bill that would boost investment in the National Institutes of Health by $3 billion but is also missing some key health measures. The bill left out a provision that would reduce drug companies’ share of costs when beneficiaries reach the Medicare donut hole, as well as the CREATES Act, which would crack down on delay tactics pharmaceutical companies use to prevent competition of cheaper generic drugs. The bill also did not include a fix to stabilize the Affordable Care Act markets.

Spending Bill Opens Path for Gun Violence Research

The funding bill opens the path for public health research into gun violence. Such research by the CDC had been banned under the 1996 legislation known as the “Dickey Amendment,” but the new provision partially alters that ban, according to The Wall Street Journal. The Dickey Amendment was supposed to prevent the CDC from advocating for gun control, but it had been interpreted as a blanket prohibition on gun violence research. The new provision will allow CDC to conduct research on the public health impact of gun use, but still prohibits the agency from advocating for gun control.

FDA Guidance on Postmarketing Safety Reporting

The FDA has released new guidelines on extending the postmarketing safety reporting requirements for some combination treatments. FierceBiotech reported that one draft guidance provides clarity on meeting requirements, as well as streamlining opportunities, and the second outlines the compliance policy.