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Rx Drugs

November 16, 2018 | Daily News

Incoming Senate Finance Committee chairman Charles Grassley (R-IA) and Senate Democratic Whip Dick Durbin (D-IL) on Friday asked the Trump administration to put in place by year’s end its proposal to require drug manufacturers disclose list prices in direct-to-consumer advertising, and they also called on HHS and CMS to adopt additional drug-price disclosure measures.

November 16, 2018 | Daily News

Sen. Charles Grassley (R-IA) is returning to chair the Finance Committee after a hiatus as Judiciary chair, and the move gives advocates for lower drug prices an ally on the committee with jurisdiction over Medicare and Medicaid that they do not have in the current Finance Chair Sen. Orrin Hatch (R-UT), who is retiring.

November 16, 2018 | Daily News

Lead sponsors Sens. Charles Grassley (R-IA) and Patrick Leahy (D-VT) are divided on whether they would still back a bill to support generic drug development if a pro-pharma provision were added to reverse changes Congress made to Medicare Part D payments in the coverage gap.

November 15, 2018 | Daily News

HHS Secretary Alex Azar doubled down on the Trump administration’s controversial plan to lower Medicare Part B drug costs by relying on international reference prices in a speech to the Commonwealth Fund International Symposium on Health Care Wednesday.

November 15, 2018 | Daily News

Potential incoming Energy & Commerce health subcommittee chair Rep. Anna Eshoo (D-CA) wants to hold hearings before developing her prescription drug policy priorities, she told Inside Health Policy on Tuesday (Nov. 13).

November 15, 2018 | Daily News

FDA drug center director Janet Woodcock said rising drug prices are changing the nature of debate surrounding the agency’s drug development requirements.

November 15, 2018 | Daily News

FDA Commissioner Scott Gottlieb tried to assure a National Academies of Sciences, Engineering and Medicine (NASEM) committee that while the agency plans to develop and publish prescribing guidelines for acute pain, the agency does not intend to regulate the practice of medicine.

November 15, 2018 | Daily News

FDA on Tuesday (Nov. 13) moved toward fulfilling provisions in the 21st Century Cures Act that allow FDA to waive or alter informed consent regulations for minimal risk clinical investigations as long as there are appropriate human subject protections in place.

November 14, 2018 | Daily News

CMS Administrator Seema Verma said Wednesday (Nov. 14) the administration is committed to giving drug plans more leverage to negotiate lower prices for drugs in protected classes.

November 14, 2018 | Daily News

Michigan has become the second state to gain CMS permission to enter into outcome-based contracts with drug manufacturers under its Medicaid program, CMS Administrator Seema Verma announced at the Prevision Policy Biopharma Congress on Tuesday.

November 13, 2018 | Daily News

The American Medical Association recommends capturing outpatient charity care provided by hospitals and stand-alone physicians in determining 340B eligibility, and the doctors group agreed to discuss with specialists what 340B eligibility criteria to give policymakers, according to a preliminary readout of the group’s House of Delegates interim meeting this week.

November 13, 2018 | Daily News

A leading public health advocate official is hopeful the incoming Democratic-led House will investigate FDA’s controversial approval of the sufentanil drug DSUVIA.

November 13, 2018 | Daily News

A health care lawyer said a bill recently introduced in the Senate that would give FDA authority to require generic drug manufacturers update their labels would be greatly improved if it included liability protection for generics.

November 13, 2018 | Daily News

Express Scripts is introducing an optional formulary for drugs with alternative drug codes, which starts the move from so-called spread pricing based on rebates to a system that shares those rebates at the pharmacy counter, the pharmacy benefit manager announced Tuesday (Nov. 13).

November 13, 2018 | Daily News

Vermont is studying whether the state could save money on prescription drugs in its Medicaid program by condensing its supply chain and purchasing drugs directly from wholesalers.

November 12, 2018 | Daily News

Democratic governor-elects across the country have lamented high prescription drug prices and proposed aggressive new policies to address the issue, including importing drugs from Canada, starting outcome-based prescription drug payments, and creating anti-price gouging standards.

November 12, 2018 | Daily News

In its latest bid to tackle the problem of drug shortages, FDA plans to collect and analyze the information it gathers from inspections of sterile injectable drug manufacturing facilities in hopes of spotting and resolving problems before shortages occur.

November 12, 2018 | Daily News

Health care watchers predict that if OTC monograph reform legislation does not make it to the president before the end of the year, renewed debates around the legislation’s industry incentives could stall the bill in 2019, especially if New Jersey Democrat Frank Pallone, who was critical of the incentives included in the House-passed bill, becomes the new Energy & Commerce chair.

November 09, 2018 | Daily News

Rep. Anna Eshoo announced Friday (Nov. 9) her bid to chair the House Energy & Commerce health subcommittee, which is expected to be a key position given Democrats’ campaign promises to work on health care policies and control drug prices.

November 09, 2018 | Daily News

FDA is taking steps to both improve its existing Expanded Access Program and simultaneously implement the recently enacted Right to Try law, which agency commissioner Scott Gottlieb stressed Thursday (Nov. 8) are separate distinct pathways by which certain patients can get experimental drugs.

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