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Rx Drugs

September 17, 2018 | Daily News

The Senate voted 98-to-2 for legislation to stop all health plans and pharmacy benefit managers in the commercial market from using gag orders to prevent pharmacists from telling customers, unless asked, when it is cheaper to buy drugs without insurance.

September 17, 2018 | Daily News

The Justice Department’s antitrust division approved, without conditions, Cigna’s proposed $67 billion purchase of Express Scripts, despite concerns that allowing the insurer and pharmacy benefit manager to merge could lead to higher drug prices.

September 17, 2018 | Daily News

FDA’s recent proposal to establish “a collaborative community” of stakeholders to support the agency in its decision-making process for diagnostics regulation could also serve as “a compelling new paradigm” for the cancer research community, Commissioner Scott Gottlieb said at a Friends of Cancer Research event Thursday (Sept. 13).

September 17, 2018 | Daily News

Seven major health organizations, including the Consumer Healthcare Products Association, Pew Charitable Trusts and American Academy of Pediatrics, are urging Congress to swiftly pass legislation that would reform the system under which over-the-counter (OTC) drugs are regulated and brought to market.

September 17, 2018 | Daily News

Faster FDA generic drug approvals could help a group of hospitals that are creating their own generic drug making company avoid shortages and price spikes, according to a report by PwC’s Health Research Institute.

September 14, 2018 | Daily News

FDA Commissioner Scott Gottlieb said his agency is discussing with public and private payers the possibility of establishing a subscription-based reimbursement policy that offers an incentive for drug makers to develop new antibiotics while health care providers are pressed to cut down on use of those drugs.

September 14, 2018 | Daily News

The director of public health at Pew Charitable Trusts applauded a broad strategy laid out by FDA Commissioner Scott Gottlieb Friday (Sept. 14) that aims to curb the growth of antibiotic resistant bacteria by facilitating new antibiotic product development using new reimbursement incentives, supporting antimicrobial stewardship, enhancing antimicrobial resistance surveillance and advancing regulatory science.

September 14, 2018 | Daily News

Three former high-ranking FDA and HHS officials said Stacy Cline Amin, the agency’s newly named chief counsel and former special assistant and senior associate counsel to the president, is more than qualified for her position in terms of education and experience.

September 13, 2018 | Daily News

The House Energy & Commerce Committee passed a number of Medicaid and anti-fraud bills on Thursday (Sept.13), including a one-year extension of the Medicaid Money Follows the Person demonstration and a tweaked version of the ACE Kids Act.

September 13, 2018 | Daily News

The Senate will vote on a package of opioid legislation Monday (Sept. 17), according to a spokesperson from Sen. Mitch McConnell’s (R-KY) office and the Senate Democrats’ online schedule.

September 13, 2018 | Daily News

FDA issued 54 product-specific drug guidances -- 42 new and 12 revised -- on Thursday (Sept. 13), saying the guidances will encourage generic drug development and increase patient access to generic and complex drugs, including those that currently lack competition.

September 13, 2018 | Daily News

Lawmakers stripped a measure to require that drug companies list prices in drug advertisements from appropriations legislation because it was too controversial with House GOP lawmakers, Senate appropriations conferees said Thursday (Sept. 13).

September 12, 2018 | Daily News

The White House’s budget office is reviewing a Medicare Part D proposed rule that could include some of the president’s proposals to control drug prices, but the rule is no longer designated as economically significant.

September 12, 2018 | Daily News

Several dozen provider groups are urging CMS to return to its previous policy of prohibiting Medicare Advantage plans from using step therapy for Part B drugs.

September 12, 2018 | Daily News

Two drug industry lawyers, one of whom works for a rare disease-focused nonprofit, have drafted a proposal for FDA to create a rare disease center of excellence similar to the agency’s Oncology Center of Excellence, which was established in 2017.

September 11, 2018 | Daily News

Hospitals sued HHS Tuesday (Sept. 11) for what they say is an unreasonable delay of a rule laying out 340B ceiling prices and penalties for manufacturers, noting the administration has pushed back implementing the rule on five separate occasions.

September 11, 2018 | Daily News

FDA published an internal policy laying out how drug center staff should prioritize drug manufacturing facilities for routine current good manufacturing practice (CGMP) surveillance inspections.

September 10, 2018 | Daily News

Sen. Mike Lee put a hold on a popular bill to stop private health plans and pharmacy benefit managers from using gag orders to prevent pharmacists from telling customers, unless asked, when it is cheaper to buy drugs without insurance, a spokesperson for the Utah Republican said.

September 10, 2018 | Daily News

Major health care and drug industry stakeholders are concerned the Drug Enforcement Administration's (DEA's) proposal to cut manufacturing quotas for certain opioids by 10 percent could exacerbate drug shortages and have a negative effect on patients with a legitimate need for opioids.

September 10, 2018 | Daily News

As stakeholders urge the Drug Enforcement Administration to rethink its proposed cuts to opioid production quotas, which they fear could cause increased drug shortages, one health policy expert argues the quotas are unlikely to have that much of an effect on the drug supply, especially as most of the highly publicized shortages are a result of manufacturing and facility issues.

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