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Rx Drugs

January 24, 2019 | Daily News

FDA issued two draft guidances on Thursday (Jan. 24) that lay out a framework for drug and biologic companies to evaluate their risk management programs, one describing how to develop an assessment plan and the second proposing ways to gauge patient or health care provider knowledge.

January 24, 2019 | Daily News

As FDA and Congress take steps toward enhancing reliance on over-the-counter and nonprescription medicine, the OTC drug lobby group, Consumer Healthcare Products Association, continues to advocate for passage of OTC monograph reform legislation, incentivizing OTC drug makers to help spur prescription-to-OTC switches, and oversight of dietary supplements, CHPA President and CEO Scott Melville told Inside Health Policy.

January 23, 2019 | Daily News

The president, HHS secretary and other administration officials touted the administration’s efforts to lower drug prices at a White House meeting Wednesday (Jan. 23) where the president talked of his amazement upon recently learning that generics work as well as the brands they copy.

January 23, 2019 | Daily News

Despite opposition from industry, FDA is not budging from its plan to require that drug and biologics makers with a product approved through the accelerated approval pathway disclose that information on the product’s Indications and Usage section and include a statement explaining that continued approval may be subject to additional trials to confirm the drug’s clinical benefit.

January 22, 2019 | Daily News

In a win for the generic drug industry, the Supreme Court unanimously ruled Tuesday (Jan. 22) that secret sales of inventions start the one-year clock to file patents.

January 18, 2019 | Daily News

CMS proposed Friday (Jan. 18) to share with insurers savings from lower Part D catastrophic spending in return for plans agreeing to penalties when they exceed spending targets.

January 17, 2019 | Daily News

Three years after publishing a draft guidance on rare disease drug development, FDA on Wednesday (Jan. 16) released a revised version of the guidance that agency commissioner Scott Gottlieb said will “provide additional advice to innovators on how they can pursue more efficient, effective development programs.”

January 16, 2019 | Daily News

In a new draft guidance released Wednesday (Jan. 16), FDA provides recommendations to generic drug makers on how to prepare and submit changes to their tentatively approved drug applications so they can receive final lawful approval on the earliest date possible based on patent and exclusivity protections.

January 16, 2019 | Daily News

Premier Inc. announced on Monday (Jan. 14) it has formed a company intended to help address drug shortages.

January 11, 2019 | Daily News

Senate Finance Committee Chairman Sen. Chuck Grassley (R-IA) will discuss a bill on pharmacy benefit manager transparency this session with his committee, a spokesman for the senator told Inside Health Policy.

January 11, 2019 | Daily News

The Senate has added to its list of active legislation the House-passed pandemic and emergency preparedness bill, which features language that would reform the way FDA regulates over-the-counter drugs and establish a user fee program for OTC products.

January 10, 2019 | Daily News

Democratic and independent lawmakers, including two potential contenders for the 2020 presidential nomination, called on President Donald Trump to support a package of three aggressive bills intended to lower prescription drug prices.

January 10, 2019 | Daily News

Newly tapped Senate Finance Chair Chuck Grassley (R-IA) said Wednesday (Jan. 9) he opposes Medicare drug price negotiation, but he seemed to imply he’s open to either changing or eliminating the risk corridors that help protect Part D drug plans from losing money.

January 10, 2019 | Daily News

Senate Finance Committee Chair Chuck Grassley (R-IA) said he is waiting to see what CMS formally proposes before passing judgment on the International Pricing Index demonstration, but he nevertheless opposes the most important aspect of the informal proposal: indexing U.S. drug prices to those set by foreign countries.

January 09, 2019 | Daily News

Over the next five years, FDA hopes to grow its electronic safety surveillance system, known as Sentinel, into a national data and scientific resource that functions as a multi-purpose center for evidence generation, FDA Commissioner Scott Gottlieb wrote in an FDA Voice blog on Wednesday (Jan. 9).

January 09, 2019 | Daily News

Incoming House Oversight & Reform Committee Chairman Rep. Elijah Cummings (D-MD) and Reps. Peter Welch (D-VT) and Joe Neguse (D-CO) will join original sponsors Sen. Bernard Sanders (I-VT) and Rep. Ro Khanna (D-CA) in supporting a bill that would expand the Trump administration’s international reference pricing concept to span the entire U.S. drug market and would give the government power to invalidate brand-drug makers’ exclusivity if their drug prices are deemed excessively high.

January 09, 2019 | Daily News

As one of his first actions as governor, California Gov. Gavin Newsom (D) ordered the state health department to consolidate purchasing power for prescription drugs under its Medicaid program.

January 09, 2019 | Daily News

FDA Commissioner Scott Gottlieb reiterated over the weekend (Jan. 5 and 6) that the agency will not accept any new abbreviated new drug applications for generic drugs during the government shutdown, and said that funding to review some pending brand-drug and biologic applications will run out in about a month.

January 08, 2019 | Daily News

The House late Tuesday (Jan. 8) passed, for the second time in the past month, a legislative package that would both reauthorize a number of hazard preparedness programs and reform the way FDA regulates over-the-counter (OTC) drugs.

January 08, 2019 | Daily News

FDA is setting up a new Office of Drug Evaluation Science (ODES) that will act as a centralized point of information for various performance metrics and provide more predictable and efficient assessment of safety data, FDA Commissioner Scott Gottlieb announced Tuesday (Jan. 8).

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