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Rx Drugs

April 05, 2019 | Daily News

FDA will consider the extent to which a drug’s intended population is expected to use the product for off-label uses when deciding whether to require a risk mitigation program for certain drugs, a policy the brand industry had alleged may exceed the agency’s statutory authority.

April 05, 2019 | Daily News

After his tenure ends Friday, FDA Commissioner Scott Gottlieb will return to the conservative American Enterprise Institute, a group that has been a favorite resource on drug-pricing issues for Republicans.

April 05, 2019 | Daily News

FDA and Customs and Border Protection (CBP) signed an agreement Thursday (April 4) to expand how information is shared between the two agencies and coordinate shared space to target entry of illicit drugs coming into the country through international mail facilities (IMFs).

April 05, 2019 | Daily News

The overhaul of the Medicare and Medicaid drug rebate systems would be handled as a voluntary two-year pilot starting in 2020, according to CMS guidance.

April 05, 2019 | Daily News

The overhaul of the Medicare and Medicaid drug rebate systems would be accompanied by a voluntary two-year pilot starting in 2020, according to CMS guidance.

April 04, 2019 | Daily News

The House Ways & Means Committee is expected to hold a hearing next week on four bipartisan bills aimed at lowering prices after the House Energy & Commerce Committee this week passed six separate bipartisan bills aimed at speeding generic drug competition.

April 04, 2019 | Daily News

Senate health committee chair Lamar Alexander highlighted some suggestions for lowering prescription drug costs that he received from think tanks and stakeholders during a floor speech Thursday (April 4).

April 04, 2019 | Daily News

The White House budget staff are reviewing CMS’ final rule to lower Part D drug costs, which might include eliminating coverage protections in six drug classes, according to the Office of Management and Budget website.

April 04, 2019 | Daily News

Days before the end of his tenure at FDA, agency commissioner Scott Gottlieb laid out a roadmap for FDA to shape its regulatory system for drug compounding in 2019.

April 04, 2019 | Daily News

FDA will host a public hearing on May 31 to gather information about the health and safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds, including cannabidiol (CBD), to help shape the agency’s regulatory oversight of cannabis, especially in food, the agency announced Tuesday (April 2).

April 04, 2019 | Daily News

Outgoing FDA chief Scott Gottlieb pinpointed complex generic and second-to-market novel drug development as two key areas in which he thinks the agency could have an effect in the drug pricing arena.

April 04, 2019 | Daily News

Departing FDA Commissioner Scott Gottlieb plans to return to his role at the American Enterprise Institute as a resident fellow and focus on the hot-button issue of drug pricing, he told the Washington Post.

April 03, 2019 | Daily News

The House Energy & Commerce Committee voted unanimously Wednesday (April 3) for six bills to cut drug prices after Democrats agreed to changes sought by Republicans to CREATES and pay-for-delay bills.

April 03, 2019 | Daily News

Rep. Mark Meadows (NC) is writing what he says is a comprehensive drug-pricing bill with fellow House Republicans that could expand rebate reforms to the commercial market, the Freedom Caucus chair told Inside Health Policy Wednesday (April 3).

April 03, 2019 | Daily News

Senate Republicans are buckling down on making prescription drug pricing a top health care priority after President Donald Trump upended their health care agenda last week by asking GOP senators to devise a plan to replace the Affordable Care Act.

April 03, 2019 | Daily News

Sen. Elizabeth Warren (D-MA) applauded FDA for funding research on durations of use for antibiotics in food animals.

April 02, 2019 | Daily News

The Senate on Tuesday (April 2) passed a bill to stop drug companies from avoiding Medicaid rebates by misclassifying brand drugs as generics, sending the first drug-pricing bill of this Congress to the president’s desk.

April 02, 2019 | Daily News

Ranking House Energy & Commerce Committee Republican Greg Walden (OR) said the two parties seem to have worked out differences on FDA-related drug pricing bills that the committee will mark up Wednesday (April 3).

April 02, 2019 | Daily News

Rep. Michael Burgess said maybe Medicare and Medicaid should cover insulin without cost-sharing because the cost to the health care system of diabetics rationing the drug is likely greater than the additional cost of covering it outright.

April 02, 2019 | Daily News

FDA will host a public hearing May 13 to gather input from stakeholders on what the agency could do to spur the first-ever availability of interchangeable prescription insulin products, coming as lawmakers criticize insulin makers for increasing prices to the point that some patients haven’t been able to afford the life-saving products.

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