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Rx Drugs

November 20, 2018 | Daily News

Sen. Bernard Sanders (I-VT) and Rep. Ro Khanna (D-CA) on Tuesday (Nov. 20) unveiled a prescription drug-pricing bill that blends Republican and Democratic proposals: The legislative plan would expand the Trump administration’s international reference pricing concept to span the entire U.S. drug market and includes a Democratic proposal to give the government power to invalidate brand-drug makers’ exclusivity if their drug prices are deemed excessively high.

November 20, 2018 | Daily News

FDA is proposing to try out a minimally invasive dog drug study that the agency hopes will encourage industry to pursue similar studies, or ones that do not involve live dogs at all.

November 19, 2018 | Daily News

Some lawmakers and congressional staff don’t expect a big legislative push for 340B reform in the next Congress, but Rep. Buddy Carter (R-GA) says he is optimistic his legislation to boost the program’s transparency and reporting could gather bipartisan support.

November 19, 2018 | Daily News

Kaleo CEO Spencer Williamson offered to lower the $4,100 price of the opioid overdose reversal drug Evzio as long as insurers give patients greater access to it, during his appearance on CBS’ “60 Minutes” on Sunday.

November 19, 2018 | Daily News

FDA Commissioner Scott Gottlieb said the agency hopes to boost its use of real-world evidence and other tools to analyze drug performance and support new indications, and he announced FDA will issue a framework to evaluate the use of RWE.

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.

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