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The administration’s proposal to require disclosure of list prices for drugs could hurt Medicare and Medicaid beneficiaries, PhRMA claimed in a 30-page comment on CMS’ proposed rule. Read More
The Justice Department says a series of whistleblower lawsuits against 10 drugmakers is not worth the government’s time or resources to pursue. Read More
HHS would be authorized to manufacture generic drugs in certain circumstances under proposed bills introduced on Tuesday in the Senate and House. Read More
Regulators are more likely to tolerate uncertainty if sponsors can show that the benefits of a proposed biomarker far outweigh the risks or if they can demonstrate that they’ve got an effective risk mitigation plan in place. Read More
Almost 60 percent of the FDA’s staff will be retained to handle core agency activities if the federal government shuts down at midnight Friday, according to an existing contingency plan for fiscal 2019 — which HHS may update this week. Read More
Two different interests groups have asked a federal judge in Washington, D.C., for a chance to make their case against CVS’ proposed $69 billion acquisition of Aetna. Read More
Four democratic senators introduced legislation aimed at ending “predatory” pricing of insulin and other life-saving drugs. The bill would give HHS authority to block any price increases on drugs that it deems “unjustified.” Read More