Politics, Policy & Law

Travel ban blocks team from receiving ASH accolades

A team of researchers from several German institutions were unable to receive an award at the American Society of Hematology meeting in Orlando this month because the presenting scientist was barred from entering the country....

USMCA deal gives China a ‘greenlight to steal American intellectual property’ BIO CEO says

Democrats have prevailed in their fight to remove a guarantee of market exclusivity for biologics from the United States Canada Mexico Agreement, infuriating the biopharmaceutical industry. BIO and PhRMA condemned President Donald Trump and House...

Forward movement on drug pricing bill, enactment uncertain

Chairs of the Republican-controlled Senate Health Committee and the Democratic-controlled House Energy & Commerce Committee have agreed to support the Lower Health Care Costs Act of 2019 (S. 1895), giving the bill added momentum amid...

Revised Grassley, Wyden drug pricing bill more patient- and pharma-friendly

Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) Friday released a revised version of the Prescription Drug Pricing Reduction Act of 2019 that includes changes that would help Medicare beneficiaries and the biopharmaceutical industry. The...

Patient alliance calls for harmonized European HTA assessments

A rare disease patient group is urging the EU Council to ensure greater transparency and harmonization in Europe’s health technology assessment process by supporting proposed rules that would obligate member states to use joint clinical...

H.R. 3 to pass House next week, dead on arrival at Senate

The House will vote next week on H.R. 3, which has been renamed the Elijah E. Cummings Lower Drug Costs Now Act, House Democratic leaders said in a statement released Thursday. The House is certain...

Democratic drug pricing bill would kill 100 drugs in 10 years, White House economic advisers say

The White House Tuesday attacked the Lower Drug Costs Now Act of 2019 (H.R. 3), a bill supported by House Speaker Nancy Pelosi (D-Calif.), and reiterated its support for the Prescription Drug Pricing Reduction Act...

Senate HELP committee endorses Hahn as FDA commissioner

The Senate Health, Education, Labor and Pensions Committee voted 18-5 on Tuesday to approve Stephen Hahn’s confirmation as FDA commissioner. HELP Committee chairman Lamar Alexander (R-Tenn.) said he hopes the full Senate will hold a...

Patient, medical groups urge quick confirmation of Hahn as FDA commissioner

Over 40 patient and medical groups have urged the Senate to rapidly confirm Stephen Hahn as FDA Commissioner. The groups sent a letter to Senate leaders on Monday, one day before the Health, Education, Pensions...

FDA moves to waive immunogenicity studies for biosimilar insulin

FDA issued draft guidance on Tuesday that would streamline the approval process for certain biosimilar or interchangeable insulin products by eliminating the need for costly and time-consuming comparative clinical immunogenicity studies. In the guidance, the...

Pioneering FDA commissioner Frank Young dies at 88

Frank Young, who served as FDA Commissioner from 1984 to 1989, a pivotal and tumultuous era in drug regulation, died Nov. 24 at age 88. He was diagnosed last week with B Cell Lymphoma. Former...

Debating the fate of innovation

No one believes that H.R. 3, the Democratic House leadership’s drug pricing bill, will be enacted into law , but that hasn’t stopped it from precipitating frenzied debates. The bill has become a strawman for advocates...

DeGette, Upton launch 21st Century Cures 2.0 focused on digital health, access to innovation

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) have revived their partnership and issued a call for ideas for policies to include in version 2.0 of the 21st Century Cures Act. The bipartisan pair launched...

National Academies report recommends greater transparency, collaboration between regulatory agencies

A report by the National Academies of Sciences, Engineering and Medicine recommends that FDA, EMA and other drug regulatory agencies tear down walls that limit information sharing and increase collaboration in order to avoid redundant...

Trump administration signals international pricing index, importation rules are advancing

The Trump administration Wednesday published clues about pending proposed rules that would create a foreign reference pricing benchmark for Medicare Part B drug prices and allow importation of prescription drugs. The White House Office of...