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Rx Drugs

April 26, 2019 | Daily News

FDA is convening two of its advisory committees to discuss safety concerns and clinical usefulness of higher-strength and higher daily doses of opioids during a meeting slated for June 11, the agency announced Friday (April 26).

April 26, 2019 | Daily News

FDA launched an educational campaign to help consumers understand how to dispose of unused opioid medications in their homes.

April 26, 2019 | Daily News

Drug-pricing policies in Japan, Korea, Canada and elsewhere are undermining innovation and curbing market access, the Office of the U.S. Trade Representative says in its annual Special 301 report on the intellectual property practices of U.S. trading partners.

April 25, 2019 | Daily News

Leading consumer advocacy groups say the public health stakes are high in a Freedom of Information Act (FOIA) case heard by the Supreme Court this week, warning in an amicus brief that a decision to tighten restrictions on what information can be released would virtually dry up data the groups have obtained from FDA.

April 25, 2019 | Daily News

Information about a drug’s effectiveness compared to alternative treatments could help drug makers argue for formulary placement in a system without rebates, Deloitte’s head of life sciences said.

April 24, 2019 | Daily News

Siding with brand-drug makers, the Commerce Department on Wednesday (April 24) said the government should clarify that high drug prices are no basis for breaking patents.

April 24, 2019 |

The House Energy & Commerce health subcommittee will hold a hearing Tuesday (April 30) on the cost of drugs in Medicare Part B and Part D as members prepare to take up bills to lower drug costs for seniors.

April 24, 2019 | Daily News

The House Energy & Commerce health subcommittee will hold a hearing Tuesday (April 30) on the cost of drugs in Medicare Part B and Part D as members prepare to take up bills to lower drug costs for seniors.

April 24, 2019 | Daily News

Arizona is the third state to require that insurance plans count copay coupons toward enrollees’ out-of-pocket costs, though the law aligns more closely with a recent CMS proposal than similar bills in Virginia and West Virginia. Gov. Doug Ducey (R) signed the law April 11.

April 23, 2019 | Daily News

CMS proposed Tuesday (April 23) policy changes that would significantly increase Medicare pay to hospitals for administering expensive CAR-T cancer drugs and make it easier for hospitals to get the maximum possible reimbursement for administering the chimeric antigen receptor T-cell therapies.

April 23, 2019 | Daily News

FDA again is extending the period of time during which it will not enforce certain combination product postmarketing safety reporting requirements, the agency announced via an updated guidance on Tuesday (April 23).

April 23, 2019 | Daily News

Ohio Attorney General Dave Yost (R) on Monday (April 22) called for the Ohio legislature to enact four policies targeting spread pricing practices by pharmacy benefit managers that would route all state drug purchases through a single PBM contract, give the state auditor unrestricted authority to review all PBM drug contracts, make PBMs fiduciaries and ban nondisclosure agreements regarding drug pricing with the state.

April 23, 2019 | Daily News

FDA and Duke University’s Robert J. Margolis, MD, Center for Health Policy will host a meeting May 16 to gather input on how to apply the agency’s benefit-risk framework throughout the human drug lifecycle and how to communicate information relating to benefit-risk assessments.

April 22, 2019 | Daily News

Medicare Trustees lowered their estimated spending projections for retail drugs in large part because rebates are bigger than they expected, and the health insurance lobby says that finding bolsters their case against HHS’ plan to eliminate rebates.

April 22, 2019 | Daily News

A measure that would allow Florida to import prescription drugs from Canada is likely to pass the state legislature before it adjourns on May 3, the senate president’s office said Friday (April 19).

April 22, 2019 | Daily News

In the wake of a 35-day partial government shutdown that furloughed 41 percent of the agency’s staff earlier this year, a group of FDA policy experts sent a letter to the agency asking for more details on how much funding FDA had and from what sources; exactly how many personnel were exempted, excepted and furloughed throughout the shutdown; and how FDA is preparing for future shutdowns.

April 18, 2019 | Daily News

CMS announced Thursday (April 18) that it will allow exchange plans to stop allowing copay coupons from drug makers to count toward enrollees’ out-of-pocket maximums when generic equivalents are available.

April 17, 2019 | Daily News

Drug discount managers, switches, pharmacy services administrative organizations, third-party vendors: Those are new types of companies that could elbow their way into the new system that would be created by drug-rebate reforms.

April 12, 2019 | Daily News

Sources say a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress -- could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.

April 11, 2019 | Daily News

Congressional Medicaid advisers voted unanimously Thursday (April 11) to recommend removing the drug-rebate cap in Medicaid, a recommendation that also is backed by the Trump administration and a key House Republican, after several MACPAC members grew comfortable with removing the cap since initially expressing doubts at a March meeting.

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