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Rx Drugs

October 11, 2019 | Daily News

The Congressional Budget Office estimates that House Democrats’ bill to negotiating drug prices would save taxpayers $345 billion in six years, but that savings would come at the cost of 8 to 15 fewer drugs being invented over a decade -- FDA approves about 30 new drugs annually.

October 09, 2019 | Daily News

In line with House Republicans, Blue Dog Democrats on Tuesday (Oct. 8) urged House Speaker Nancy Pelosi to hold votes on several bipartisan drug pricing bills, instead of wrapping them into government price negotiation legislation that Republicans oppose.

October 08, 2019 | Daily News

HHS sent a draft guidance of its drug importation plan to the Office of Management and Budget on Monday (Oct. 7), the same day that both White House Domestic Policy Council head Joe Grogan and former FDA Commissioner Scott Gottlieb said they expect the administration to approve Florida’s Canadian importation plan.

October 08, 2019 | Daily News

Public Citizen is calling on FDA to withdraw approval of all hydroxyprogesterone caproate-containing drugs, including the brand drug Makena, which are used to reduce risk of preterm birth in women.

October 08, 2019 | Daily News

Democratic presidential candidate Pete Buttigieg released Monday (Oct. 7) a plan to lower drug prices that resembles government price negotiation legislation orchestrated by House Speak Nancy Pelosi (D-CA), and the South Bend, IN, mayor included a measure that liberals back to let the government break patents.

October 04, 2019 | Daily News

FDA on Friday (Oct. 4) called for groups to submit research proposals for the agency’s Safe Use Initiative, which fosters collaborations with the health care community to reduce preventable harm from medication use.

October 04, 2019 | Daily News

FDA approved the second HIV prevention drug, Descovy, Gilead said Thursday (Oct. 3), setting the stage for difficult coverage decisions as Gilead touts Descovy as safer than its other HIV prevention drug, Truvada, a year before Truvada goes generic.

October 03, 2019 | Daily News

President Donald Trump said Thursday (Oct. 3) that his administration will “soon” allow states to import drugs from Canada.

October 03, 2019 | Daily News

A prominent Canadian patient advocate alleged a U.S.-based biologics industry group is engaging in “fearmongering” in her country as part of a bid to reduce confidence in biosimilars, but the targeted group, the Alliance for Safe Biologic Medicines, told Inside Health Policy it is merely raising legitimate concerns over Canada’s new policy that requires biosimilar switching without the involvement of physicians.

October 03, 2019 | Daily News

Senate Finance Chair Chuck Grassley (R-IA) could lose leverage if the panel’s bipartisan drug pricing package is delayed until early 2020, but he would gain political maneuvering time, sources said.

October 03, 2019 | Daily News

FDA awarded a grant to the National Association of Boards of Pharmacy to set up an information-sharing system for drug compounding activities that are primarily overseen by states, the agency announced Wednesday (Oct. 2).

October 02, 2019 | Daily News

President Donald Trump tweeted Wednesday (Oct. 2) that House Speaker Nancy Pelosi (D-CA) is “incapable” of working on legislation to lower drug prices and is using the issue to distract from House Democrats’ impeachment inquiry.

October 02, 2019 | Daily News

House Energy & Commerce Committee Democrats are considering changes to a measure in their drug pricing bill that would hurt many nonprofit hospitals by eliminating 340B discounts on drugs that are subject to government price negotiation.

September 30, 2019 | Daily News

The proposed 2021 Notice of Benefit and Payment Parameters, which will lay out exchange-related policies and is expected to include revised guidance on drug co-pay coupons that was delayed for 2020, is now under review by the White House Office of Management and Budget.

September 30, 2019 | Daily News

FDA on Monday (Sept. 30) issued a draft guidance detailing the methods and best research practices stakeholders, especially drug makers, can use to find out what’s important to patients, including identifying the burdens of living with and treating a disease, as well as the benefits and risks in managing a disease.

September 27, 2019 | Daily News

FDA is creating new Sentinel Coordination Centers via a five-year contract as part of its bid to grow the agency’s flagship Sentinel System into a vigorous national scientific resource, the agency announced Friday (Sept. 27).

September 26, 2019 | Daily News

FDA’s plan to streamline its reviews of new drugs through a major reorganization effort has been approved by Congress, agency drug center director Janet Woodcock announced Thursday (Sept. 26).

September 25, 2019 | Daily News

Senate Finance Chair Chuck Grassley said he hopes to rally support from the president and more lawmakers for the drug pricing package he sponsored with Finance ranking Democrat Ron Wyden (OR) after the full bill text’s expected release Wednesday (Sept. 25) evening.

September 25, 2019 | Daily News

FDA on Tuesday (Sept. 24) announced the first FDA-approved vaccine for both monkeypox and smallpox, a disease that FDA biologics director Peter Marks said many Americans have no immunity to and that could pose a national security threat if it were released intentionally.

September 24, 2019 | Daily News

The House Democrats’ impeachment inquiry all but kills the chances of House Speaker Nancy Pelosi (D-CA) striking a deal on drug pricing with President Donald Trump, lobbyists and analysts say, though they had always said there was little prospect in government drug price negotiation becoming law.

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