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Rx Drugs

March 23, 2018 | Daily News

In long-awaited guidance released Friday (March 23), FDA laid out a two-part test on how the agency will determine whether there is a clinical need for 503B compounders to make drugs with bulk substances, rather than FDA-approved drugs.

March 23, 2018 | Daily News

Sen. Ron Johnson (R-WI) unsuccessfully attempted after midnight to pass via unanimous consent the House-passed Right to Try bill.

March 22, 2018 | Daily News

The omnibus appropriations bill did not include a measure, backed by brand drug companies, to lower their share of Medicare Part D coverage-gap costs, and a measure on biosimilars pass-through pay that was included in the spending bill seems tailored to a specific product.

March 21, 2018 | Daily News

Although unreleased at press time, the omnibus appropriations bill is not expected to include a measure, backed by brand drug companies, to lower their share of Medicare Part D coverage-gap costs, congressional staff and drug lobbyists say.

March 16, 2018 | Daily News

Newly published research from the Patent Trial and Appeal Board finds that Orange Book-listed patents fare significantly better during inter partes reviews than other patents.

March 16, 2018 | Daily News

Should House lawmakers' updated federal Right to Try bill eventually be passed through Congress and signed into law, provisions in state laws that some have called anti-patient, like those allowing insurers to deny coverage to those using Right to Try drugs, would not be preempted by the federal law, legal experts tell Inside Health Policy.

March 15, 2018 | Daily News

The House Rules Committee will hold a hearing Monday (March 19) on the Right to Try bill that failed to pass the House under suspension of the rules last week, the committee announced Thursday (March 15).

March 15, 2018 | Daily News

Safety-net hospitals and drug makers each said Thursday (March 15) that they support transparency, but such requirements need to be applied to all sectors that profit from drug sales.

March 15, 2018 | Daily News

The House Energy & Commerce health subcommittee announced on Wednesday (March 14) the slate of 21 bills it intends to discuss during its two-day hearing on legislation that could help stem the opioid crisis.

March 14, 2018 | Daily News

Academics who have backed changing the 340B program are calling for tweaks to 340B-overhaul bills, the 340B PAUSE and 340B HELP Acts, to better account for safety-net services.

March 14, 2018 | Daily News

America's Health Insurance Plans has chosen its chief operating officer, Matt Eyles, as the group's new president and CEO, the trade group announced Wednesday (March 14).

March 14, 2018 | Daily News

Like their colleagues in the Senate did last month, members of the House Energy & Commerce health subcommittee considered Wednesday (March 14) draft language to reauthorize the Animal Drug User Fee Agreement (ADUFA) and the Animal Generic Drug User Fee Agreement (AGDUFA).

March 13, 2018 | Daily News

Brand drug lobbyists say there is a decent chance Congress will lower drug companies’ share of Medicare Part D donut-hole costs by 5 percent to 6 percent as lawmakers could provide that much relief without increasing the deficit due to an updated estimate by the Congressional Budget Office, though drug makers are unlikely to get more than that because lawmakers don’t want to negotiate offsets.

March 13, 2018 | Daily News

FDA Chief Counsel Becky Wood’s recent remarks that FDA is taking a “risk-based approach” toward warning letters, focusing on “significant public health risks, rather than overly technical or insignificant violations,” left one industry attorney pleased, pharma critics frustrated and some policy watchers waiting for more details before predicting how the Trump FDA will deal with off-label promotion.

March 12, 2018 | Daily News

House Energy & Commerce Committee Republicans’ attempts to craft a Right to Try bill that patient advocates can support appears to have failed, with major groups refusing to back anything that cuts FDA out of the process.

March 09, 2018 | Daily News

A fundamental change in manufacturing would be needed for the United States to shift from “antiquated” egg-based flu vaccines to newer technologies like cell-based vaccines and recombinant DNA technology, which could pave the way toward a universal vaccine, government experts told lawmakers March 8.

March 09, 2018 | Daily News

503B compounder Cantrell Drug Company and FDA have reached a temporary agreement to reinspect the facility after FDA moved to force the company to shut down and the compounder filed a subsequent restraining order against the government, according to a new document filed in the case on Friday (March 9).

March 09, 2018 | Daily News

Pew Charitable Trusts reports that rescinding protected drug classes likely would not save that much money because generic competition is strong in those drug classes, plans already can restrict coverage using other tools and Medicare requirements that are separate from protected class status might prevent plans from excluding drugs anyway.

March 08, 2018 | Daily News

The 503B compounding pharmacy that FDA and the Department of Justice are asking a federal judge to shut down is fighting back, using its bankruptcy to request a temporary restraining order that would halt any government action for 45 days.

March 08, 2018 | Daily News

The Senate health committee sent stakeholders a draft of its cosmetics bill, obtained by Inside Health Policy, in a bid to gather input on the proposed federal oversight reforms, which include allowing HHS to suspend facilities or ingredient listing, requiring manufacturers to report adverse events to HHS within a set period of time, mandating manufacturing and processing facilities register with HHS, establishing labeling requirements, and allowing HHS to inspect facility records if it believes a cosmetic product is adulterated and can cause serious adverse health consequences.

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