SPECIAL REPORT

Gottlieb's First 100 Days

Over the coming days, Inside Health Policy will roll out a series of articles based on conversations with key stakeholders regarding their impressions of Gottlieb’s progress thus far, and where they see him taking the agency on key issues, including: off-label promotion, regulatory reform and drug pricing.

Senate Will Not Vote On Drug-Pricing Bills Before August Recess
July 24, 2019

The Senate will not vote on drug pricing legislation before the August recess, key committee chairs said Wednesday (July 24).

FDA Clears Mustard Gas Treatment As Part Of Countermeasures Effort
July 24, 2019

FDA on Monday (July 22) cleared a wound dressing used to treat first- and second-degree burns caused by exposure to sulfur mustard, also known as mustard gas.

CBO: Budget Deal Extends Medicare Sequestration To 2029
July 23, 2019

The budget and debt ceiling deal reached by Congress and the White House extends sequestration on Medicare through 2029 to help pay for higher budget caps on FDA and other nondefense agencies -- a move the Congressional Budget Office says will increase spending by around 2% for most Medicare benefits through September 2027.

Expert: Budget Deal Good For FDA, Offsets Won’t Affect Agency
July 23, 2019

An FDA expert said the two-year deal reached by Congress and the White House on Monday (July 22) to raise the government’s budget caps is good for FDA in that it moves Congress closer to passing a 6% funding increase for the agency for fiscal 2020.

Finance Committee Unveils Details Of Monumental Drug-Pricing Bill
July 23, 2019

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.

Finance GOP Still Balking At Inflation Caps, Dems Want Drug Negotiation
July 23, 2019

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).

FDA Launches First E-Cigarette Prevention TV Ads, Ramps Up Education
July 22, 2019

FDA launched its first e-cigarette prevention television ads Monday (July 22).

Lawmakers To FDA: Speed Review Of Bulk Drug Substances For 503B List
July 19, 2019

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.

Public Citizen To Senate: Revive Controversial FDA Generic Label Rule
July 19, 2019

Public Citizen wants the Senate to mandate FDA re-issue the controversial proposed rule on generic drug labeling that it scrapped late last year.

Experts Suggest Orphan Drug Act Reforms To Stem Drug Prices
July 18, 2019

A pair of researchers from Harvard Medical School call for reforms to the Orphan Drug Act to help stem rising drug prices.

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