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Rx Drugs

November 25, 2019 | Daily News

When President Donald Trump took to Twitter Friday (Nov. 22) to weigh in on drug pricing reforms, he gave House Republicans cover to vote against House Democrats’ bill to let Medicare negotiate drug prices, instead of leaning on Senate Republicans to support the less-aggressive bipartisan drug pricing legislation in that chamber, even though White House adviser Joe Grogan said recently that the administration backs the Senate bill.

November 22, 2019 | Daily News

A bipartisan group of lawmakers, led by Reps. Cindy Axne (D-IA) and Anthony Gonzalez (R-OH), are pressing HHS Secretary Alex Azar for answers about the ongoing shortage of pediatric cancer drug vincristine.

November 21, 2019 | Daily News

Lawmakers on both sides of the aisle lobbed questions and expressed concerns about issues related to drug pricing, such as drug importation, biologic patent gaming, generic drug exclusivity and insulin access, to FDA commissioner-nominee Stephen Hahn during his Senate confirmation hearing Wednesday (Nov. 20).

November 21, 2019 | Daily News

FDA approved a drug for sickle cell anemia that could pose a significant cost to state Medicaid budgets because a little more than half of the approximate 100,000 Americans living with sickle cell disease are in Medicaid and the annual cost of the drug is $84,852 to $113,136, based on list price.

November 21, 2019 | Daily News

Democratic presidential primary candidate Elizabeth Warren says that during the first 100 days of her presidency she would lower brand drug prices and tackle drug shortages with strict antitrust enforcement, and compulsory licensing and march-in authorities.

November 20, 2019 | Daily News

During the Senate health committee’s confirmation hearing for FDA commissioner-nominee Stephen Hahn on Wednesday (Nov. 20), lawmakers grilled the nominee on myriad issues, including drug pricing, generic drug approvals, drug shortages and e-cigarette regulations.

November 20, 2019 | Daily News

HHS plans to propose this month the controversial International Pricing Index demonstration that the president announced in October of 2018, according to the fall regulatory agenda that the administration published Wednesday (Nov. 20).

November 19, 2019 | Daily News

The House Judiciary Committee will mark up on Wednesday (Nov. 20) a bill to deter patent gaming by allowing the Federal Trade Commission to prosecute pharmaceutical manufacturers that try to engage in product hopping.

November 19, 2019 | Daily News

The Center for Science in the Public Interest (CSPI) is asking FDA and the Federal Trade Commission to take enforcement action against more than 25 companies that market dietary supplements with the claim that they will treat female infertility.

November 18, 2019 | Daily News

Brand and generic drug companies disagree over the usefulness of FDA’s and the Federal Trade Commission’s efforts to address gaming of FDA’s risk mitigation strategies, according to a report published by the Government Accountability Office (GAO) Thursday (Nov. 14).

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.

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