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Rx Drugs

January 31, 2020 | Daily News

The Trump administration proposed to expand its copay accumulator policy to let plans exclude drug makers’ coupons from counting towards enrollees’ out-of-pocket maximums even when there is no generic option available.

January 31, 2020 | Daily News

The medical device lobby is actively working with the Chinese and U.S. governments and stakeholders to ensure providers and patients have access to medical technologies that can help diagnose and prevent the spread of novel coronavirus, the group told Inside Health Policy on Thursday (Jan. 30), amid reports that China is experiencing shortages of masks, gowns and gloves.

January 31, 2020 | Daily News

The White House budget office completed its review of FDA’s proposal that would allow institutions conducting research through multiple sites in the United States to rely on approval by a single Institutional Review Board.

January 30, 2020 | Daily News

CMS’ new policy that ties closed Medicaid drug formularies to block grants is a double whammy for the drug industry because sources say block grants amplify the negotiating power of closed formularies.

January 30, 2020 | Daily News

The House Energy & Commerce health subcommittee on Wednesday (Jan. 29) discussed several legislative proposals that aim to reform drug manufacturing, update generic drug labels and increase FDA’s authorities over imported medical devices.

January 30, 2020 | Daily News

The over-the-counter drug lobby will broaden its focus to include consumer medical devices, and it plans to work with FDA to establish a definition and standards separate from those used to regulate more traditional medical devices, the Consumer Healthcare Products Association told Inside Health Policy.

January 28, 2020 | Daily News

House Democratic leadership is pushing committee chairs to conclude work on surprise billing legislation by Feb. 13 so they have enough time to negotiate a drug pricing deal before the May 22 deadline for renewing health care extenders, sources say.

January 28, 2020 | Daily News

FDA, the National Institutes of Health and the Office of the Assistant Secretary for Preparedness and Response are researching possibilities for vaccines, diagnostics and therapeutics to respond to the novel coronavirus, of which there are now five known cases in the United States, HHS Secretary Alex Azar said during a press briefing Tuesday (Jan. 28).

January 28, 2020 | Daily News

House Majority Leader Steny Hoyer (D-MD) says he is open to compromising with Senate Republicans and the White House on drug pricing legislation, though he doubts House Democrats will soften their stance on Medicare price negotiation.

January 28, 2020 | Daily News

The House Energy & Commerce health panel will review legislative proposals that aim to end gaming of the Orphan Drug Act, improve generic drug labeling and foster continuous manufacturing at a legislative hearing Wednesday (Jan. 29).

January 28, 2020 | Daily News

FDA’s Office of Prescription Drug Promotion (OPDP) will study the role of endorsers, including celebrities, in direct-to-consumer advertising, the agency informed the White House budget office Monday (Jan. 27).

January 27, 2020 | Daily News

Diagnostic test makers who want to pursue emergency use authorization for tests to detect novel coronavirus should contact FDA, the agency said in a press release Monday (Jan. 27) as part of an update on the agency’s response efforts.

January 27, 2020 | Daily News

The future direction of the generic drug market is in question as the industry experiences increased competition among multiple companies all vying for the same molecule.

January 27, 2020 | Daily News

House Speaker Nancy Pelosi’s (D-CA) top health aide Wendell Primus told lobbyists in closed-door meetings that he’s open to negotiating with Republicans on whether to let Medicare bargain with drug companies over prices, sources who recently met with Primus told Inside Health Policy.

January 27, 2020 | Daily News

FDA has extended the comment period for its draft guidance that lays out flexible approaches for demonstrating effectiveness for certain new drugs and biologics, the agency announced Friday (Jan. 24).

January 24, 2020 | Daily News

FDA’s declaration Wednesday (Jan. 22) that Chiesi’s hypertension drug Cardene (nicardipine hydrochloride) was not withdrawn for safety and efficacy reasons opens the door for generic manufacturers, such as Baxter, to make the drug and may help resolve current shortages of nicardipine hydrochloride, a pharmacy group says.

January 23, 2020 | Daily News

The House Energy & Commerce Committee health subcommittee will hold a hearing on Jan. 29 to discuss legislative proposals aimed at improving the safety of food and drugs and increasing regulatory transparency, the subcommittee announced Wednesday (Jan. 22).

January 23, 2020 | Daily News

New Mexico Gov. Michelle Lujan-Grisham (D) is proposing to create an office that would develop a plan to import Canadian drugs.

January 22, 2020 | Daily News

FDA plans to address challenges in developing products to treat rare disorders, including what a key stakeholder views as a first-ever agency focus on individualized treatments, at a public meeting slated for Feb. 24.

January 21, 2020 | Daily News

FDA Deputy Director of Regulatory Programs Doug Throckmorton assured lawmakers during a recent hearing that the agency doesn’t need more authority from Congress to regulate cannabidiol (CBD) products.

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