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Daily News

July 18, 2019

House Republicans want FDA to expand the Parallel Track pathway, which currently provides patients with HIV and AIDS drugs that have not been FDA approved but are being studied in clinical trials, to include potential therapies for debilitating diseases such as Alzheimer’s and cancer.

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FDA took another step to help speed up access to generic drugs by publishing draft guidance that explains how drug makers can better use the Inactive Ingredient Database (IID) in drug development, including to evaluate the safety of inactive ingredients, also known as excipients.

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Reckitt Benckiser Group, which used to own Suboxone maker Indivior, has agreed to pay $700 million to the federal government and $50 million to settle Federal Trade Commissioner charges that the company violated antitrust laws in an attempt to thwart generic competition to the opioid addiction treatment drug Suboxone.

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Free-market think-tank Pacific Research Institute released a report Thursday (July 11) that pinpoints market practices -- such as low biosimilar reimbursement, step therapy policies and anti-competitive contracting practices -- and lack of education from FDA on interchangeability and biosimilar safety as the biggest obstacles to biosimilar competition.

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House lawmakers have reintroduced a bill that would require FDA, in consultation with the National Institute on Drug Abuse (NIDA), to issue guidelines on the production of marijuana as part of the legislation’s larger goal to amend the Controlled Substances Act to make marijuana accessible to researchers for medical purposes.

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FDA Principal Deputy Commissioner Amy Abernethy will discuss hemp production during a July 25 Senate agriculture committee hearing, the committee announced Wednesday (July 17).

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The National Milk Producers Federation (NMPF) complained to FDA on Wednesday (July 17) that the agency has yet to resolve issues surrounding its standard of identity for milk, namely whether plant-based products should be called “milk.”

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July 17, 2019

The House late Wednesday passed 419 to 6 legislation to fully repeal the Affordable Care Act’s 40% tax on high-cost health plans, also known as the Cadillac tax, a key priority for a broad array of health care stakeholders, including issuers, employers, unions and others.

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The House Energy & Commerce Committee added an arbitration backstop to its surprise billing legislation, making the House bill notably different from the Senate version, which could cause problems when the bill goes to conference.

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CMS Administrator Seema Verma on Wednesday (July 17) touted the revamped accountable care organization program, which kicked in July 1, for leading more ACOs to take on risk, but the National Association of ACOs is worried that fewer new ACOs appear to be joining the program.

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The Supreme Court likely will hear arguments in December over whether the government is obligated to pay out about $12 billion owed to issuers participating in the ACA’s risk corridors program, presuming the court agrees to a recently proposed briefing schedule.

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The House Energy & Commerce Committee on Wednesday (July 17) unanimously approved legislation that would delay Disproportionate Share Hospital (DSH) cuts, reauthorize Medicaid funding to the territories with increased oversight of Puerto Rico’s funding, fund community health centers and other extenders for four years, and tackle surprise billing.

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Senate Finance Committee Republicans asked HHS Secretary Alex Azar on Wednesday (July 17) to provide them with information about Medicaid spending and fraud control in Puerto Rico in light of the recent corruption scandal in the Puerto Rican government.

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Senate Finance Committee Republicans asked HHS Secretary Alex Azar on Wednesday (July 17) to provide them with information about Medicaid spending and fraud control in Puerto Rico in light of the recent corruption scandal in the Puerto Rican government.

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The Treasury Department on Wednesday (July 17) issued guidance listing 14 preventive drugs and services used for common chronic conditions -- including insulin, statins and beta-blockers -- that now can be covered pre-deductible by health plans linked to health savings accounts (HSAs), responding quickly to President Trump’s June 24 executive order that directed the department explore the change.

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National Kidney Foundation leaders expressed hope signals from the White House that FDA, CMS and the Center for Medicare & Medicaid Innovation (CMMI) are interested in advancing renal replacement therapies or devices could encourage more investment in medical product development for kidney disease.

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July 16, 2019

Senate Republicans tried to quickly move the health committee’s broad legislative package through the floor via a procedural move but hit a snag when several senators objected due to concerns over the surprise billing provisions, according to lawmakers -- signaling that the legislation likely won’t be easily passed like lawmakers originally predicted.

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Senate Republican leadership hotlined the health committee’s broad cost-cutting package in order to ascertain GOP concerns and discovered several senators were prepared to hold up floor action over the surprise billing provisions -- signaling that Senate leaders have work cut out for them before they can move broader legislation that is expected to merge the health committee's bill with drug-pricing measures from the Finance and Judiciary committees.

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CMS on Tuesday (July 16) repealed a prohibition on nursing homes using pre-dispute, binding arbitration agreements with residents, but the final rule also says nursing homes can’t require residents to sign binding arbitration agreements as a condition of admission or to continue receiving care at a facility.

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CMS on Tuesday (July 16) proposed to loosen regulatory requirements for nursing homes by rolling back numerous safety and compliance provisions of an Obama-era rule that the agency now says is overly burdensome.

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