Rx Drugs

FDA took another step to help speed up access to generic drugs by publishing draft guidance that explains how drug makers can better use the Inactive Ingredient Database (IID) in drug development, including to evaluate the safety of inactive ingredients, also known as excipients.

Free-market think-tank Pacific Research Institute released a report Thursday (July 11) that pinpoints market practices -- such as low biosimilar reimbursement, step therapy policies and anti-competitive contracting practices -- and lack of education from FDA on interchangeability and biosimilar safety as the biggest obstacles to biosimilar competition.

Senate Republicans tried to quickly move the health committee’s broad legislative package through the floor via a procedural move but hit a snag when several senators objected due to concerns over the surprise billing provisions, according to lawmakers -- signaling that the legislation likely won’t be easily passed like lawmakers originally predicted.

The Congressional Budget Office on Tuesday (July 16) reported that the wide-ranging Senate health committee bill, which aims to end surprise medical billing, increase transparency and lower prescription drug and other health costs, would save about $7.6 billion over 10 years, largely due to expected decreases in federal spending on insurance premiums as a result of the surprise billing provisions.

Lawmakers and federal agencies tasked with monitoring illicit drug flow, including FDA and Customs and Border Protection, pinpointed a lack of data sharing among agencies as a challenge in combating the illicit flow of fentanyl into the United States.

Democratic presidential candidate Sen. Amy Klobuchar (D-MN) released a plan for seniors on Friday (July 12) that includes a number of Medicare proposals, including expanding Medicare services for Alzheimer’s patients, supporting site-neutral payments and expanding telehealth, as other presidential hopefuls begin to release their own health plans.

Democratic presidential candidate Joe Biden over the weekend added himself to the list of Democrats pushing for Medicare drug price negotiation, and his plan includes a foreign-price component that takes a page from President Donald Trump’s plan to tie Medicare Part B drugs to foreign prices.

CMS is working on possible changes to the end stage renal disease pay system as part of a broader kidney care revamp unveiled by HHS Wednesday (July 10), as the agency says that “continual refinement of the ESRD PPS is necessary to benefit people living with ESRD.”

House Speaker Nancy Pelosi (D-CA) is negotiating with the White House on a government drug price negotiation plan that spans Medicare Part D, Part B and Medicaid, and the Federal Trade Commission or the Veterans Health Administration would arbitrate when HHS officials and drug company executives fail to agree on price, according to sources briefed on the latest proposal.