A recently issued final FDA guidance clarifies key industry questions about how combination product makers should comply with postmarket safety reporting requirements (PMSR), but an industry lawyer said some of the finer points, such as details to be included in foreign event reports and the number of constituent parts in a safety report, will have to be hashed out in practice.
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Rx Drugs
July 31, 2019 |
Daily News
In light of a deadly pig disease sweeping across China, bipartisan leaders of the House Energy & Commerce Committee want FDA to brief lawmakers on the potential threat to the U.S. supply of heparin, the only anticoagulant drug used in the United States for open-heart surgeries and kidney dialysis.
July 31, 2019 |
Daily News
The Trump administration’s newly unveiled two-track plan to allow drug importation was touted as a precedent-setting move by HHS officials, but some health policy experts said it could slow up state importation efforts through unnecessary rulemaking and do little to lower drug costs under the voluntary, industry-driven track.
July 30, 2019 |
Daily News
Public Citizen wants the Federal Trade Commission (FTC) to block the merger between Mylan and Pfizer’s Upjohn, which the companies announced Monday (July 29).
July 30, 2019 |
Daily News
The leaders of the Senate Finance and health committees met Tuesday (July 30) to begin cross-committee talks on drug pricing, the chairmen said.
July 29, 2019 |
Daily News
Drug makers would pay a significantly larger share of costs in Medicare Part D under the Senate Finance Committee’s new drug-pricing plan, according to Senate Finance Chair Chuck Grassley’s (R-IA) office.
July 26, 2019 |
Daily News
Senate Finance Chair Chuck Grassley (R-IA) on Thursday (July 25) warned fellow GOP senators that the drug pricing bill he negotiated with ranking Democrat Ron Wyden (OR) is moderate compared to policies being considered by the Trump administration and House Democrats.
July 25, 2019 |
Daily News
Freedom Caucus Chair Mark Meadows (R-NC) said Thursday (July 25) it is “very likely” the Trump administration will take its own steps to lower drug prices in Part D, though the details are in flux. Meadows said he attended a drug-pricing meeting Wednesday between President Donald Trump and drug lobbyists that was first reported by Politico.
July 25, 2019 |
Daily News
Thirteen Republican senators and one Democrat voted Thursday (July 25) to kill President Donald Trump’s plan to connect Medicare payment for physician-administered drugs to foreign drug prices in a rebuke of one of the administration’s last remaining drug-pricing policies.
July 25, 2019 |
Daily News
In a tie vote, an amendment to repeal a key measure of the Senate Finance Committee’s drug-pricing bill failed Thursday (July 25).
July 25, 2019 |
Daily News
House Energy & Commerce member William McKinley (R-WV) hopes to eliminate legal barriers to generic market entry through legislation that would narrow the situations in which brand-drug makers can litigate patents while still maintaining intellectual property protections.
July 24, 2019 |
Daily News
Acting FDA Commissioner Ned Sharpless told agency staff in an email Tuesday (July 23) that his top priorities are to develop frameworks for regulating new technologies; invest in the agency’s workforce; help to lower drug prices by encouraging drug competition; and improve postmarket surveillance of regulated products.
July 24, 2019 |
Daily News
The Senate will not vote on drug pricing legislation before the August recess, key committee chairs said Wednesday (July 23).
July 23, 2019 |
Daily News
The White House expressed support on Tuesday (July 23) for the Senate Finance Committee’s new drug-pricing bill as did the generic drug lobby, but the brand-drug lobby came out against it.
July 23, 2019 |
Daily News
The Senate Finance Committee unveiled a long-awaited drug-pricing bill, to be marked up Thursday (July 25), that includes monumental changes to drug-pricing policy in Medicare and Medicaid -- including restructuring the Part D benefit, imposing controversial inflationary rebates in Medicare Parts B and D, and raising the rebate cap in Medicaid.
July 23, 2019 |
Daily News
Lawmakers on the Senate Finance Committee did not hesitate to criticize the grand drug-pricing bargain Senate Finance Chair Chuck Grassley (R-IA) and ranking Democrat Ron Wyden (OR) rolled out Tuesday (July 23).
July 22, 2019 |
House Speaker Nancy Pelosi’s drug-price negotiation bill will be unveiled in early September to give drug makers less time to undermine the plan over the August recess and the Congressional Budget Office more time to formally score the bill, senior Pelosi aide Wendell Primus said Monday (July 22).
July 22, 2019 |
Daily News
The HHS Office of Inspector General says a lack of transparency on which drugs are part of the 340B program may have caused Part D plans to lose tens of millions of dollars in drug rebates from manufacturers in 2014, and the costs to Part D may have increased since because more pharmacies have joined the 340B program.
July 19, 2019 |
Daily News
Executives from Pfizer, Genentech, Amgen and Alkermes met with White House officials Thursday (July 18) to discuss policies to control drug prices, according to sources familiar with the meeting.
July 19, 2019 |
Daily News
House lawmakers want FDA to expedite its review of drug substances nominated for inclusion on the agency's list of bulk substances that can be compounded based on a clinical need.
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