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Emergency Response

June 22, 2020 | Daily News

Former U.S. Department of Agriculture Secretary Tom Vilsack said Congress should provide more financial resources to the agriculture sector and USDA to help solve issues highlighted by the current COVID-19 pandemic.

June 09, 2020 | Daily News

FDA announced Monday evening (June 8) it would adjust the Prescription Drug Marketing Act to temporarily allow for prescription medication to be distributed directly to patients through the mail in response to repeated clarification requests from the industry during the declared COVID-19 national emergency.

June 09, 2020 | Daily News

FDA announced Monday (June 8) it will temporarily allow manufacturers to mail prescription drug samples directly to patients’ homes, upon request from a health care provider, to facilitate access to medications for patients who typically obtain samples from their doctors.

June 01, 2020 | Daily News

FDA has created a voluntary online form through which certain FDA-regulated food facilities can report a temporary stop or significant slowdown in production during the COVID-19 pandemic, as well as request help from the agency on how to safely continue or restart food production.

May 28, 2020 | Daily News

Regulatory lawyers agree with former FDA chief Scott Gottlieb’s calls for the Centers for Disease Control and Prevention to release up-to-date information about COVID-19.

May 26, 2020 | Daily News

A new agreement between FDA and the U.S. Department of Agriculture solidifies USDA’s authority to invoke the Defense Production Act to force food harvesting, processing and manufacturing facilities, including plants typically regulated by FDA, to remain open during COVID-19, one food industry lawyer told Inside Health Policy.

May 21, 2020 | Daily News

Health policy experts say HHS’ move this week to expand drug manufacturing capacity in the United States through a new public-private partnership with Phlow Corporation is a good first step toward ramping up domestic production, but they also caution it’s too soon to tell whether the move will have any real, lasting impact on the overall pharmaceutical supply chain.

May 12, 2020 | Daily News

House Democrats’ latest COVID-19 response legislation, The Heroes Act (H.R. 6800), would increase FDA’s authority to secure the medical supply chain, enhance FDA’s authority to regulate medical devices, and require HHS to track the availability of COVID-19 diagnostic and serology tests.

May 07, 2020 | Daily News

National Institutes of Health Director Francis Collins suggested federal researchers should, with appropriate consent, track individuals who have tested positive for COVID-19 antibodies to see whether they develop the disease later down the road.

May 07, 2020 | Daily News

House Speaker Nancy Pelosi (D-CA) told reporters Wednesday (May 6) that the chamber’s next stimulus package will include Energy & Commerce health subcommittee Chair Anna Eshoo’s (D-CA) bill that calls for an expert committee to assess the U.S. drug supply chain and recommend ways to reduce dependence on foreign drug manufacturing.

May 06, 2020 | Daily News

FDA released a temporary guidance Wednesday (May 6) requiring that manufacturers notify the agency of any significant disruption in the medical device supply chain during a public health emergency, in a bid to mitigate devices shortage amid the COVID-19 crisis.

May 01, 2020 | Daily News

During the COVID-19 public health emergency, FDA will not require third-party certification bodies, which conduct foreign food facility inspections, to be audited in person, and the agency will allow certain certifications to extend beyond their original expiration date.

April 29, 2020 | Daily News

Watchdog groups say the White House’s new executive order that invokes the Defense Production Act to keep meat processing plants open during the COVID-19 public health emergency prioritizes corporations over employee safety and effectively takes away the ability for workers to sue if they contract the disease at work.

April 29, 2020 | Daily News

FDA recently released a temporary enforcement policy stating it does not intend to pursue regulatory action over distribution of unapproved computerized behavioral therapy and other digital health devices during the COVID-19 pandemic.

April 27, 2020 | Daily News

Two major pharmacy associations on Monday (April 27) released draft guidelines to help state boards of pharmacy ensure compounding pharmacies comply with FDA’s recent guidance that temporarily eases restrictions on pharmacy compounders and allows pharmacists to compound drugs for hospitals without first receiving a patient-specific prescription.

April 27, 2020 | Daily News

The Indian Pharmaceutical Alliance is urging FDA to conduct desk reviews, including virtual inspections, of certain drug manufacturing facilities in India for the duration of the COVID-19 pandemic as a way to proceed with facility inspections and mitigate future drug shortages.

April 23, 2020 | Daily News

Democrats are asking the HHS Inspector General to investigate whether a key HHS official in the government’s response to the pandemic was ousted for pushing back against the president’s promotion of hydroxychloroquine as a COVID-19 treatment.

April 22, 2020 | Daily News

Outsourcing facilities worry FDA’s move to let pharmacists compound drugs for hospitalized COVID-19 patients without a prescription could hurt larger compounders and put patients at risk due to insufficient production standards.

April 17, 2020 | Daily News

Sen. Patty Murray (D-WA) on Friday (April 17) asked FDA Commissioner Stephen Hahn whether he was pressured by the White House on the agency’s COVID-19 response, specifically FDA’s emergency use authorization (EUA) for hydroxychloroquine and chloroquine to treat COVID-19, and asked Hahn to commit to base FDA’s decisions on science alone.

April 16, 2020 | Daily News

FDA cleared the way for hospitals to dispense at-home blood glucose monitoring devices to COVID-19 patients so they can self-test while in the hospital, which device companies and FDA say can reduce burden on, and risk to, health care workers while also protecting diabetes patients who have compromised immune systems.