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Rx Drugs

December 19, 2019 | Daily News

Leading lawmakers on the House Energy & Commerce Committee pegged the United States’ reliance on foreign manufacturing of generic drugs as a top-line issue they will tackle in 2020.

December 18, 2019 | Daily News

Senate Finance Committee Chair Chuck Grassley said Senate Majority Leader Mitch McConnell (R-KY) told fellow Republicans to withhold support for the Finance drug pricing bill, but the Iowa Republican hopes to build support by negotiating with the House and urging the president to add his personal touch to the White House’s backing of S. 2543.

December 18, 2019 | Daily News

The Trump administration on Wednesday moved forward on its plan to let states and drug makers import lower-cost prescription drugs from other countries.

December 18, 2019 | Daily News

The Trump administration on Wednesday moved forward on its plan to let states and drug makers import lower-cost prescription drugs from other countries.

December 18, 2019 | Daily News

The Trump administration on Wednesday moved forward on its plan to let states and drug makers import lower-cost prescription drugs from other countries.

December 17, 2019 | Daily News

Stephen Hahn, shortly after being sworn in as FDA commissioner on Tuesday (Dec. 17), emailed FDA staff that he’s optimistic about continuing to advance FDA’s talent, expertise and infrastructure, and said he will adhere to sound data and uphold the law.

December 17, 2019 | Daily News

FDA recently detailed how it will execute its new authorities to require sponsors of molecularly targeted adult cancer drugs to submit data on how those drugs can also be used in pediatric populations.

December 17, 2019 | Daily News

FDA unveiled a draft proposal for a new qualification process for drug development tools, including biomarkers, clinical outcome assessments, and other methods or materials used to aid in drug development and regulatory review.

December 17, 2019 | Daily News

A new study released Tuesday (Dec. 17) by the Pharmaceutical Research and Manufacturers of America says that 340B hospitals are, on average, reimbursed by commercial insurers at about three times what they pay for drugs under the discount program.

December 16, 2019 | Daily News

Congress included the pro-generic CREATES Act to help pay for five months of so-called Medicare and Medicaid “extenders” in the one-year government funding bill, plus a few minor biologics policies.

December 16, 2019 | Daily News

Congress is creating a new opening to vote on surprise billing and drug pricing legislation next May by limiting Medicare and Medicaid extenders to five months in a year-long government funding bill. 

December 13, 2019 | Daily News

An FDA analysis shows the average manufacturer price (AMP) for generic drugs can be up to 54% lower than the brand drug price before competition when there are at least two generic competitors on the market.

December 13, 2019 | Daily News

FDA issued a final rule Friday (Dec. 13) withdrawing a regulation that requires drugs sterilized by irradiation to submit a new drug application (NDA) or an abbreviated new drug application (ANDA).

December 13, 2019 | Daily News

The House rejected a GOP drug pricing proposal that, among its slew of bipartisan provisions, calls for reforming FDA’s over-the-counter drug monograph regulatory framework and establishing a user fee program for OTC drugs.

December 12, 2019 | Daily News

House Democrats on Thursday (Dec. 12) unanimously voted to pass Speaker Nancy Pelosi’s drug pricing bill, and two Republicans crossed party lines to support H.R. 3, too.

December 12, 2019 | Daily News

Federal lawmakers from California grilled the American Kidney Fund over its decision to stop providing premium assistance to about 3,700 patients with end-stage renal disease, but AKF says it made it clear the charity could not operate under a recently enacted California bill and believes the state is looking for someone to blame now that about 3,700 patients will lose premium assistance.

December 12, 2019 | Daily News

FDA is demanding Alkermes stop publishing a print advertisement for its extended-release naltrexone drug Vivitrol, which is used to treat opioid addiction, because the ad fails to warn fatal overdoses could occur if the treatment lapses.

December 11, 2019 | Daily News

The House Rules Committee on Tuesday (Dec. 10) cleared House Speaker Nancy Pelosi’s drug pricing bill (H.R. 3) for a floor vote after Pelosi reached a deal with progressives to increase the minimum number of drugs subject to negotiation each year to 50 and to restore Rep. Pramila Jayapal’s (D-WA) amendment to extend price-spike protections to private plans.

December 11, 2019 | Daily News

House Energy & Commerce Committee members asked FDA drug center chief Janet Woodcock how foreign staffing shortages are limiting agency inspections of drug manufacturers abroad during an oversight hearing Tuesday (Dec. 10).

December 11, 2019 | Daily News

Sen. Ted Cruz (R-TX) and other conservative lawmakers intend to pursue an expansion of FDA’s Parallel Track program if Stephen Hahn is appointed as FDA commissioner, even though FDA already has similar programs, such as Expanded Access, already in place, as well as a new pilot program, Project Facilitate.

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