AgencyIQ Recap: New shortage requirements for devices; FDA’s evolving stance on diagnostics

Each week, the FDA publishes dozens of new policies, updates and regulations. POLITICO’s AgencyIQ analyzes these fast-moving, complex developments so you don’t have to. The following is a glimpse into what our research and news teams published this week. For more information on how you can become a subscriber of AgencyIQ and view all of our content, please contact us here.

 

 

Drugs and Biologics

FDA guidance permits exemptions from supply chain protection measures (Analysis)

Supply chain protection measures like “track and trace” help to protect against counterfeit drugs, but may also cause delays and bottlenecks during a public health emergency like COVID-19. The FDA has decided to temporarily exempt certain transactions in an effort to get treatments where they’re needed as quickly as possible.

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Court backs up FDA on refusal to approve abuse deterrent opioid (Analysis)

A new ruling from the DC Circuit of the US Court of Appeals has upheld the FDA’s decision not to approve a drug with an abuse-deterrent formulation, a victory for the agency’s stance that drugs intended to deter abuse must substantiate those claims through special studies.

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Position Analysis: Industry recommends enhancements to FDA’s new Purple Book (Analysis)

In February, the FDA unveiled significant new improvements to its Purple Book, a database containing information about the approval status and characteristics of biological products. While the FDA says further improvements are still on the way, it has offered the life sciences industry a chance to weigh in on which improvements to make. AgencyIQ reviewed industry comments and suggestions.

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Position Analysis: Industry weighs in on FDA guidance to broaden enrollment of older adults in oncology trials (Analysis)

FDA draft guidance released in March recommended that companies enroll greater numbers of older adult patients with cancer in clinical trials to ensure that medications are known to be effective and safe in those patients most likely to make use of them. The FDA said it would consider alternative trial designs meant to help companies to ensure that data from older patients are able to be considered separately from younger, relatively healthier patients. While the life sciences industry has generally been supportive of the FDA’s proposal, some have recommended targeted improvements to the guidance.

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FDA adopts new blood donor questionnaire allowing faster donation by those at risk for HIV, malaria (Analysis)

Licensed blood establishments and blood product manufacturers will have a new set of questions to ask potential donors following the release of a final FDA guidance implementing recent policy changes intended to increase the supply of donated blood.

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Moderna speeds up timeline for potential coronavirus vaccine (News)

Moderna Therapeutics will begin Phase II trials for its government-funded coronavirus vaccine shortly and could hit the final stages of trials by “early summer,” the company announced Thursday.

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Tracking the hunt for coronavirus drugs and vaccines (News)

With coronavirus infections and deaths mounting in the United States, the race to find treatments and vaccines is accelerating. There are now 72 registered clinical trials ongoing in the U.S. and abroad, according to the Food and Drug Administration. Here’s a rundown of how this process is taking shape, and the key results expected in the coming months.

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Remdesivir helps coronavirus patients — but at what cost? (News)

Gilead has rocketed into the public consciousness with one of the most promising coronavirus treatments, but the company’s history of sky high drug pricing is drawing increasing scrutiny from Congress about how much it will charge for remdesivir and who will get access.

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FDA authorizes emergency use of coronavirus drug remdesivir (News)

The Food and Drug Administration on Friday issued an emergency use authorization for remdesivir, in a bid to help patients get quicker access to the first antiviral to show promise against Covid-19 infections.

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Medical Devices and Diagnostics

A new NIH-led interagency program aims to develop and scale up COVID-19 diagnostics (Analysis)

COVID-19 diagnostic developers could gain financial and operational manufacturing assistance and a regulatory fast-track through a new program announced by the NIH in collaboration with FDA and BARDA. While the Rapid Acceleration of Diagnostics (RADx) program is intended to incent developers to come up with novel solutions to ongoing testing capacity issues, the project’s success will depend on the regulatory competencies of participants.

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Citing legal and operational challenges, FDA backs off drug-device proposal (Analysis)

Manufacturers of devices seeking an indication for use with a particular drug will not be able to independently get a new drug indication approved without the drug sponsor’s consent following the FDA’s withdrawal of a 2017 policy proposal.

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FDA establishes new medical device shortage reporting requirements (Analysis)

Manufacturers of certain medical devices that are life-sustaining, life-supporting, or intended for use in emergency medical care are now subject to shortage reporting for the first time. The FDA issued guidance implementing the policy, which was introduced under the CARES Act in March.

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Amid mounting scrutiny, FDA overhauls antibody testing guidance (Analysis)

Serological (or “antibody”) tests are used to identify if an individual has had an immune response to a pathogen. A new FDA guidance document overturns existing FDA policy and requires that most marketed tests undergo the agency’s Emergency Use Authorization review procedure.

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Sponsors of surgical screw systems used in spinal surgeries get new clarity from FDA (Analysis)

New FDA guidance clarifies the regulatory pathways available to manufacturers of posterior cervical screw systems.

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FDA warns some masks from China don’t meet quality standards (News)

The FDA warned health care providers Thursday that it revoked its approval for certain filtering respirators from China that performed inadequately during filtration performance testing.

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FDA nixes plan to approve medical devices for use with certain drugs — even if drugmakers disagreed (News)

The Food and Drug Administration on Thursday said it would scrap a proposal that would have allowed medical device companies to submit devices for authorization that would be labeled for use with approved drugs, even without the cooperation of the companies that own the drugs.

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FDA lays out device shortage reporting requirements during coronavirus pandemic (News)

FDA has outlined what medical device shortage information it expects manufacturers to report during the coronavirus pandemic under requirements put into place by the Coronavirus Aid, Relief, and Economic Security Act.

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FDA enacts stricter rules for antibody tests after congressional investigation (News)

The agency says it is aware that some firms are promoting faulty tests.

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White Oak, White House and Congress

Frustrated doctors push administration to reveal which hospitals are getting remdesivir — and why (News)

Doctors across the country are demanding that the Trump administration explain how it is distributing the sole drug proven to help coronavirus patients to hospitals.

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Bright accuses HHS of political pressure in formal complaint (News)

Bright alleges that he was one of the few officials sounding a warning about hydroxychloroquine, the malaria medicine that the president had championed.

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Trump contradicts top health officials with vaccine timeline, malaria drug claims (News)

President promises vaccine by end of 2020, again touts unproven treatment

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Feds to pilot antibody studies in NYC, Detroit (News)

The city-led studies aim to shed light on the pandemic’s impact on people working on the front lines.

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