Posts tagged with "Acting FDA Commissioner Ned Sharpless"

A shot in the dark? Drug companies issue rare joint pledge on vaccine safety

September 9, 2020

On September 7, nine pharmaceutical companies issued a rare joint pledge—intended to reassure the American public about the safety and efficacy of the coronavirus vaccines that currently are under development.

The statement from the top drug companies working on COVID-19 vaccines—including Pfizer, AstraZeneca, and Moderna—comes amid fears that President Donald Trump will continue to place pressure on the industry to speed up the vaccine approval process without proper oversight, and doubts among the public about taking a vaccine, The Hill reports.

The joint pledge states that the companies will not seek Food and Drug Administration (FDA) approval for their vaccines until a rigorous phase 3 clinical trial shows that it is safe and that it works. 

The companies pledged they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”

The companies said they would “always make the safety and well-being of vaccinated individuals our top priority.”

Highlighting the fears of political interference, Trump on Monday floated the idea of having a vaccine before Election Day on November 3. “We’re going to have a vaccine very soon. Maybe even before a very special date. You know what date I’m talking about,” he said at a news conference.

Trump has put pressure on the FDA before, saying that the “deep state” at the agency was throwing up roadblocks before the agency issued an emergency authorization for a coronavirus treatment known as convalescent plasma.

According to The Hill, FDA Commissioner Stephen Hahn also has offered reassurances that his agency will base vaccine decisions only on science and not on politics.

But the statement from the pharmaceutical companies is an illustration of how deep the fears are about politicization of the process and the need for companies to try make their own reassurance about science guiding the process.

An NPR-PBS NewsHour-Marist poll last month found that a significant portion of the public (35%) did not intend to receive a coronavirus vaccine.

Research contact: @thehill

A remedy for rip-offs: HHS announces plans to import lower-cost drugs from Canada

August 1, 2019

The U.S. Department of Health and Human Services (HHS) announced on July 31 that the agency, in concert with the U.S. Food and Drug Administration (FDA, is publishing a Safe Importation Action Plan for procuring certain drugs originally intended for foreign markets.

Among the medications that U.S. patients would be able to procure at lower prices would be insulin used to treat diabetes, as well as drugs used to treat rheumatoid arthritis, cardiovascular disorders, and cancer.

Specifically, according to a report by the Associated Press, the Trump administration said Wednesday it will create a pathway allowing Americans to legally and safely import lower-cost prescription drugs from Canada for the first time, reversing years of opposition from federal health authorities amid a public outcry over high prices for life-sustaining medication

“President Trump has been clear: For too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices,” stated said Health and Human Services Secretary Alex Azar, adding, “When we released the President’s drug pricing blueprint for putting American patients first, we said we are open to all potential solutions to combat high drug prices that protect patient safety, are effective at delivering lower prices, and respect choice, innovation and access.”

Azar further noted, “This is the next important step in the Administration’s work to end foreign freeloading and put American patients first.”

The Action Plan outlines the government’s intention to pursue two pathways to allow safe drug importation from foreign markets:

  1. Through a notice of proposed rule-making (NPRM), HHS and FDA would propose to rely on the authority under current federal law (Federal Food, Drug, and Cosmetic Act, Section 804) that would, when the rule is finalized, authorize pilot (or demonstration) projects developed by states, wholesalers or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval. The NPRM would include conditions to ensure the importation poses no additional risk to the public’s health and safety and that the demonstration projects would achieve significant cost savings to the American consumer.
  2. Through guidance, FDA would provide recommendations to manufacturers of FDA-approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. To use this pathway, the manufacturer or entity authorized by the manufacturer would establish with the FDA that the foreign version is the same as the U.S. version and appropriately label the drug for sale in the United States. This pathway could be particularly helpful to patients who take significantly high-cost prescription drugs.

“We support the President and Secretary’s efforts to bring down drug prices for Americans. The FDA has a unique role to play in promoting competition that in turn can help reduce drug prices and improve access to medicine for Americans,” said Acting FDA Commissioner Ned Sharpless, M.D. “Driving down drug prices requires a comprehensive approach and we must continue to look at all innovative solutions to this challenge.”

Research contact: digital@hhs.gov