Premier Inc. Supports FDA, DEA Reforms and Regulatory Waivers to Counter Drug Shortages

Premier Inc. | July 24, 2020

Premier Inc. today provided the U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA) with a list of reforms and regulatory waivers that the company believes should be extended beyond the COVID-19 pandemic and made permanent thereafter in order to prevent drug shortages.

“During the height of the COVID-19 pandemic, we saw demand for many common pharmaceuticals surge by an average of more than 150 percent,” said Blair Childs, Premier’s Senior Vice President of Public Affairs. “Waivers from the FDA and DEA cleared away cumbersome barriers and helped providers manage surges in demand to avoid drug shortages. Lessons learned during the pandemic response demonstrate that these flexibilities could be implemented safely and were effective in mitigating drug shortages that otherwise could have been detrimental to patient care. The Administration should act on all these recommendations, easing regulatory burden and improving options for patients.”

Specifically, Premier recommends to the FDA that 503B compounding facilities be allowed to continue producing specific drugs that are not on the drug shortage list based on specific criteria, such as a short-term or regional shortages or demand surges for certain dosage strengths and/or packaging sizes. This waiver proved particularly helpful during the pandemic, as it allowed 503B compounders to quickly and seamlessly fill capacity gaps and alleviate spot shortages before they became severe enough to spread nationwide and make it onto the FDA drug shortage list.


"This study is a major advance," says Irene Tracey, a pain neuroscientist at Oxford University who wasn't involved in the study. "It was a tour de force and a welcome addition to understanding this complex and major problem."


"This study is a major advance," says Irene Tracey, a pain neuroscientist at Oxford University who wasn't involved in the study. "It was a tour de force and a welcome addition to understanding this complex and major problem."

Related News

Red River Biorefinery Now Producing Pharmaceutical Grade (USP) Ethanol for Hand Sanitizers and Disinfectants

Red River Biorefinery | October 06, 2020

The Red River Biorefinery (RRB) announced today that it has expanded production to supply ethanol that meets the U.S. Pharmacopeia (USP) purity and quality standards to the hand sanitizer market. To help meet the increase in global demand for hand sanitizer products due to COVID-19, RRB is now supplying hand sanitizer manufacturers with safe, high-quality ethanol products with one of the lowest carbon footprints available on the market today. It is extremely gratifying to have a local producer supplying safe ingredients for hand sanitizers while providing local jobs to support our communities. The Red River Biorefinery serves a vital role in the region's value-added agricultural, energy, and low carbon economies," said James Leiman, Director of Economic Development and Finance Division for the State of North Dakota.

Read More


AvKARE bottles mix Viagra generics with antidepressant, triggering recall

AvKARE | December 15, 2020

A conventional drugmaker with a Rolodex loaded with government customers is pulling an energizer and an erectile brokenness medications after the two were bundled together in similar containers. Pulaski, Tennessee-based AvKARE reviewed one parcel of sildenafil 100-mg tablets and one parcel of trazodone 100-mg tablets after the items were stirred up by an outsider bundling provider, the organization said before the end of last week. The jugs had just been delivered to drug stores. AvKARE markets its own private-name conventional medications to a record of government customers, including the branches of Defense, Veterans Affairs and the Health and Human Services. The organization additionally supplies the Indian Health Services, in addition to nongovernment clients around the world. The customer level review influences parts sent to merchants and wholesalers and afterward delivered out from one side of the country to the other, the organization said. The sildenafil part has a March 2022 termination date, while the trazodone parcel lapses in June 2022. AvKARE said it so far hasn't got any result reports from the reviewed parcels. Sildenafil—a nonexclusive rendition of Viagra—can blend inadequately with nitrate-containing drugs for diabetes, hypertension or coronary illness, conceivably bringing pulse down to perilous levels. The upper trazodone hydrochloride, in the interim, can cause sluggishness, dazedness, stoppage and obscured vision, AvKARE cautioned. Those results represent a more serious danger of falls and impeded driving in more seasoned clients who may have bought the organization's erectile brokenness copycat.

Read More


Ranok Therapeutics Announces Agreement with Pfizer on Targeted Protein Degradation

Ranok Therapeutics | November 30, 2021

Ranok Therapeutics Co. Ltd., an emerging biopharmaceutical company focused on developing breakthrough therapies for cancer and other serious diseases, announced an agreement with Pfizer Inc. to apply and evaluate Ranok’s CHAMP™ platform technology on an undisclosed cancer target. Terms of the agreement were not disclosed. Ranok has developed a proprietary and innovative targeted protein degradation (TPD) platform technology, CHAMP™ (Chaperone-mediated Protein Degradation), which leverages Ranok’s founders’ expertise in protein homeostasis to take advantage of the cellular chaperone network, potentially improving drug safety and efficacy due to selective targeting of disease tissues. “We are very pleased to work with Pfizer to explore the application of CHAMP™ to an emerging cancer drug target, This represents our first pharmaceutical company research relationship and is an important step forward in establishing CHAMP™ as a preferred technology in the rapidly-growing field of targeted protein degradation. We look forward to uncovering new benefits of CHAMP™ through this research.” Kevin P. Foley, Ph.D., Co-founder and Chief Scientific Officer of Ranok Therapeutics This evaluation agreement builds upon Ranok’s recent momentum, including its $40 million Series B financing in August 2021. About Ranok Therapeutics Ranok is a privately held, emerging biopharmaceutical company that is pioneering its proprietary CHAMP™ platform technology, an innovative approach to targeted protein degradation (TPD) for the discovery and development of novel therapeutics. Ranok was founded by a leadership team composed of industry veterans from both Chinese and American biotech and pharmaceutical companies and is based in two of the world’s leading centers of innovation and medical research: Hangzhou China and Greater Boston, Massachusetts. By bringing together cutting-edge medical research from both China and the United States, Ranok’s goal is to create transformative medicines to benefit patients suffering from cancer and other serious diseases around the world. For more information, please visit the company website at or follow us at LinkedIn and on Twitter @RanokTx. About Ranok’s CHAMP™ platform Chaperone-mediated Protein Degradation/Degrader technology is based on our founders’ extensive backgrounds in protein homeostasis research. This technology takes advantage of the cellular chaperone network, distinguishing it from other targeted protein degradation (TPD) approaches. CHAMP™ has a number of unique advantages, including improved safety due to the selective targeting of tumors. Our proprietary R&D engine combines deep biological insight and chemistry expertise to iteratively discover and test new leads, rapidly identifying and advancing optimal development candidates for a variety of important disease targets.

Read More