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Rx Drugs

November 15, 2019 | Daily News

FDA sent Greenbrier International Inc. (Dollar Tree) a warning letter for selling potentially harmful over-the-counter (OTC) foreign drugs, some of which were imported from China.

November 14, 2019 | Daily News

The Consumer Healthcare Products Association (CHPA) says FDA should quickly establish a regulatory pathway to allow dietary supplements containing hemp-derived cannabidiol (CBD) to be legally marketed.

November 14, 2019 | Daily News

Congress should hold hearings on the United States’ growing reliance on pharmaceuticals and active pharmaceutical ingredients (APIs) from China, and direct FDA to compile a list of Chinese-made drugs critical to American health and to certify that Chinese drug makers are up to par with U.S. standards, the U.S.-China Economic and Security Review Commission says in its new annual report released Thursday (Nov. 14).

November 14, 2019 | Daily News

Republicans on the Energy & Commerce health subcommittee say legislation to stop brands from using citizen petitions to unfairly delay generic competition might violate the First Amendment, but Rep. Morgan Griffith (R-VA) said he must do his homework before taking a firm stance on whether to make an adjustment to the bill.

November 14, 2019 | Daily News

As biologics companies urge FDA to consider allowing development of authorized biosimilars -- where a reference biologic manufacturer would make a biosimilar version of that product -- experts question whether doing so would undercut the value of biosimilar exclusivity in the same way authorized generics have been accused of undercutting generic drug incentives.

November 14, 2019 | Daily News

A shortage of vincristine, one of the drugs essential to treating pediatric cancer, has the pediatric oncology community calling for both long-term and short-term drug shortage reforms.

November 13, 2019 | Daily News

HHS Secretary Alex Azar said his agency is working at the White House’s direction to modify its International Pricing Index plan to ensure the United States pays less for drugs than other developed nations.

November 13, 2019 | Daily News

Senate Minority Leader Chuck Schumer (D-NY) blocked the passage of a bipartisan bill, introduced by Sen. John Cornyn (R-TX), that aimed to prevent drug companies from patent gaming, after Cornyn called up the bill on Wednesday (Nov. 13) for an expedited floor vote.

November 13, 2019 | Daily News

Two FDA experts say 2020 presidential hopeful Sen. Elizabeth Warren’s (D-MA) plan to weed out government corruption by restricting how companies share data and information with federal agencies could have a chilling effect on FDA and regulated industries.

November 13, 2019 | Daily News

FDA plans to host a public workshop on the benefits of incorporating clinical outcome assessments (COAs) into regulatory decision making.

November 11, 2019 | Daily News

White House Domestic Policy Council Director Joe Grogan is not a fan of including drug rebate reform in the Senate’s drug pricing bill, and he would rather spend what little time is left tweaking policies that ensure the bill doesn’t raise premiums and that spread more of the bill’s Part D savings to more seniors.

November 11, 2019 | Daily News

FDA is laying the groundwork to study how the general public interprets drug promotion.

November 08, 2019 | Daily News

White House Domestic Policy Advisor Joe Grogan suggested that lawmakers are close to an agreement on surprise billing legislation and believes that something will pass either stand alone or attached to drug pricing measures by the end of the year.

November 07, 2019 | Daily News

Dozens of hospital and pharmacy groups have thrown their support behind a bipartisan Senate bill to avert drug shortages, with sources telling Inside Health Policy some of the groups worked with the cosponsors to develop the bill.

November 07, 2019 | Daily News

Humira revenues fell 33.5% internationally in the third quarter of this year due to biosimilar competition, according to AbbVie, while revenues increased 9.6% in the United States, where there is no biosimilar competition until 2023.

November 07, 2019 | Daily News

Sen. Dick Durbin (D-IL) said Wednesday (Nov. 6) he will soon request a floor vote on legislation to require that television drug advertisements disclose list prices.

November 07, 2019 | Daily News

HHS has sued Gilead for patent infringement after the drug manufacturer repeatedly refused to obtain licenses for HHS patents on an HIV medication. The suit, filed in federal court in Delaware, alleges Gilead willfully infringed on patents given to HHS meant to protect the government’s work in developing pre-exposure prophylaxis (PrEP), and has profited from research funded by taxpayers through the sale of the brand-name drugs Truvada and Descovy, according to HHS.

November 06, 2019 | Daily News

Senate Homeland Security and Governmental Affairs Committee ranking Democrat Sen. Gary Peters (MI) on Tuesday (Nov. 5) launched an investigation to identify solutions to high drug prices and drug shortages, which he said raise serious health, economic and national security threats.

November 06, 2019 | Daily News

Senate Finance Committee Chair Chuck Grassley suggested  Tuesday (Nov. 5) that he plans to file an updated drug pricing bill next week, and a White House official said the administration is working with the Iowa Republican and ranking Finance Democrat Ron Wyden (OR) on provisions to limit seniors’ monthly out-of-pocket costs and to help seniors with sharply rising insulin list prices.

November 06, 2019 | Daily News

FDA will start picking leaders for newly formed review divisions as part of the second phase of its reorganization of the Office of New Drugs, the agency announced Wednesday (Nov. 6).

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