martes, 4 de agosto de 2020

Reminder: Webinar on FDA’s Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic



Join Us Today: Webinar on FDA’s Regulation of Face Masks and Surgical Masks during the COVID-19 Pandemic

Today, Tuesday, August 4, 12:00 p.m.-1:00 p.m. ET, the U.S. Food and Drug Administration (FDA) will host a webinar on the FDA’s regulation of face masks and surgical masks during the COVID-19 pandemic. This webinar will expand the scope of the respirator webinar series to discuss face masks and surgical masks.

During this webinar, representatives from the FDA will share information and answer questions related to face masks and surgical masks. The discussion will include the FDA’s Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) and relevant emergency use authorizations (EUAs).

We encourage all interested stakeholders to join. Registration is not necessary.

To ensure you are connected, please dial in at 11:45 a.m.

U.S. Callers Dial:
  • 888-455-1392
  • Conference Number: PWXW1573188
  • Passcode: 8364649
International Callers Dial:
  • 1-773-799-3847           
  • Conference Number: PWXW1573188
  • Passcode: 8364649
To view the slide presentation during the webinar:  https://www.mymeetings.com/nc/join.php?i=PWXW1573188&p=8364649&t=c
SAVE THE DATE:
The FDA plans to hold additional webinars every two weeks to continue to share information and answer your questions on respirators and other personal protective equipment (PPE). Save the date for the next webinar:
  • August 18, 2020, from 12:00 pm-1:00 pm ET

Questions?

If you have questions, please contact the Division of Industry and Consumer Education.

CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA



CDRH New

August 4, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 3, 2020. To view listings for other dates, see CDRH New - News and Updates.

Is the FDA ready to decide whether CBD gummy bears are legal?

D.C. Diagnosis
Nicholas Florko

Coming soon: An FDA policy on CBD? 

The FDA is about to release a long-awaited enforcement policy on cannabidiol, the marijauna-adjacent compound it has struggled to regulate for years. 

The policy is going through the formal White House vetting process now, according to a White House website. And while the FDA hasn’t released virtually any specifics about the guidance beyond its title, “Cannabidiol Enforcement Policy; Draft Guidance for Industry,” it’s already getting outsized attention.

The CBD industry wants clear rules of the road for how to sell its products, as do its congressional allies. But the FDA, which still considers CBD products illegal, has been incredibly skittish about setting any such policies. It’s even vehemently denied that it currently uses a policy of “enforcement discretion” and only going after companies flagrantly violating the law, despite the fact that the FDA has essentially used that policy for more than a year.

That lack of clarity has led some industry lawyers to insist that even a formal codification of FDA’s existing policy would be a major step forward for industry.

“The FDA has adopted a de facto enforcement policy without actually adopting an enforcement policy,” said Jonathan Havens, a partner at Saul Ewing Arnstein & Lehr.

Havens insisted that FDA formalizing the policy would show investors and retailers that the FDA feels so confident that it can safely use enforcement discretion that it was able to release a formal policy on the topic that was vetted by the White House.

In the past weeks, the White House held a series of meetings with industry groups like the National Industrial Hemp Council and Ziese Farms.

Jonathan Miller, the general counsel for the U.S. Hemp Roundtable, which represents a number of the top CBD-makers in Washington and which also sent representatives, told STAT he pitched the White House on the importance of the FDA creating a formal enforcement discretion policy or a kind of safe harbor that would allow the CBD industry to sell their products legally.

The White House is set to meet with the American Herbal Products Association and the law firm WassermanRowe later this week. 

Here comes the rebate rule food fight, part deux

The Campaign for Sustainable Rx Pricing, a coalition that includes the major lobbies for insurers, hospitals and middlemen, announced Tuesday a new advertising campaign criticizing the Trump administration's renewed push to end the system of drug rebates negotiated by drug makers and middlemen.
The ads come on the heels of a similar campaign launched last week by the Pharmaceutical Care Management Association. Both sets of ads, which direct viewers to call the White House, are the clearest sign yet that defenders of drug rebates are putting serious muscle behind efforts to make Trump’s stance a liability going into the November election.
“President Trump wants to reward big pharma’s price hikes,” the ad from CSRxP states. “Tell President Trump to stop the rebate rule now."
“The Trump administration just announced a plan to raise Medicare premiums and out of pocket costs for seniors, during a pandemic, just before an election,” the PCMA ad states. 
CSRxP is planning a “significant six-figure campaign,” according to a spokesperson. The ad will run in Washington DC and in the battleground states of Arizona, Colorado, Florida, Iowa, Maine, Michigan, North Carolina, and Wisconsin through the GOP convention. PCMA didn’t detail its buy.

It’s official: Drug makers owe the government lots of missing data 

The federal government is now warning pharmaceutical companies, device makers and universities that they have to publish missing clinical trials data “as soon as possible” — a major win for transparency advocates. It comes after a federal court ruled in February that the agency has to collect the missing data; the federal government declined to appeal that decision. For more, check out my colleague Lev Facher’s story, here

Is Gilead sitting on a potentially more effective, albeit less lucrative, Covid-19 drug?

Yes, according to a pair of researchers at MD Anderson and the advocacy group Public Citizen. The groups are out with a new open letter attempting to pressure Gilead into studying another compound in the company’s portfolio, GS-441524, that they believe might be effective in treating coronavirus — and potentially more effective and easier to manufacture than the company’s approved product, remdesivir. 
The authors claim that lab tests show the compound, is “similar or superior" to remdesivir and more easily synthesized. They also imply that that the company is uninterested in commercializing the drug because it has a shorter patent life than remdesivir. 
“It is unclear why Gilead and federal scientists have not been pursuing GS-441524 as aggressively as remdesivir, but we cannot help but note that there are significant financial incentives tied to Gilead’s current patent holdings,” the letter states. “Gilead’s monopoly power over remdesivir may have at least five additional years of enforceability beyond that of GS-441524.”
For more, STAT’s Ed Silverman has the details here.

Are drug costs going up? It depends 

Despite widespread anger over rising drug prices, consumers with insurance are being asked to pay less and less at the pharmacy counter, according to a new study from the group IQVIA. The average consumer with insurance is shelling out just $8.90 per prescription, down from the $10.83 they paid per prescription in 2015, Ed Silverman reports
The situation is much different, however, for those paying cash: The uninsured are now spending an average of $50.78 per month per prescription, which is up from $36.77 in 2015. 
The study underscores how much more complex  drug pricing policy is than a simple soundbite can convey, and it shows that consumers’ exposure to high drug prices is largely dependent on the quality of their insurance. More here from Ed.

Are drug costs going up? It depends 

Despite widespread anger over rising drug prices, consumers with insurance are being asked to pay less and less at the pharmacy counter, according to a new study from the group IQVIA. The average consumer with insurance is shelling out just $8.90 per prescription, down from the $10.83 they paid per prescription in 2015, Ed Silverman reports
The situation is much different, however, for those paying cash: The uninsured are now spending an average of $50.78 per month per prescription, which is up from $36.77 in 2015. 
The study underscores how much more complex  drug pricing policy is than a simple soundbite can convey, and it shows that consumers’ exposure to high drug prices is largely dependent on the quality of their insurance. More here from Ed.

HRSA Launches PLOS Special Collection Highlighting Ryan White HIV/AIDS Program’s Innovative Models of Care | HIV.gov

HRSA Launches PLOS Special Collection Highlighting Ryan White HIV/AIDS Program’s Innovative Models of Care | HIV.gov

HRSA Logo: Ryan White & Global HIV/AIDS Programs

HRSA Launches PLOS Special Collection Highlighting Ryan White HIV/AIDS Program’s Innovative Models of Care
The U.S. Department of Health and Human Services’ Health Resources and Services Administration has launched a new Special Collection of manuscripts this week in PLOS (Public Library of Science), highlighting Ryan White HIV/AIDS Program’s innovative approaches for data utilization and engagement of people with HIV who are not in care and not virally suppressed, critical components of the Administration’s Ending the HIV Epidemic: A Plan for America initiative.
LEARN MORE
 
Advancing the Ending the HIV Epidemic Initiative with a $109 Million Investment in 57 Areas of the United States
Last week, the Centers for Disease Control and Prevention awarded $109 million to 32 state and local health departments that represent the 57 jurisdictions across the United States prioritized in the federal initiative Ending the HIV Epidemic: A Plan for America.
LEARN MORE

A coronavirus vaccine won’t change the world right away - The Washington Post

A coronavirus vaccine won’t change the world right away - The Washington Post

The Readout

Damian Garde & Meghana Keshavan

More reads

  • A coronavirus vaccine won’t change the world right away. (Washington Post)
  • Prescription drugs may be more affordable than you think — unless you pay cash. (STAT Plus)
  • Kodak CEO got stock options day before news of loan sent stock soaring. (New York Times)
  • Johnson & Johnson spray approved to treat suicidal people. (Bloomberg)

Chief Vaccine Scientist Will Not Be Forced to Disclose Pharmaceutical Stocks - The New York Times

Chief Vaccine Scientist Will Not Be Forced to Disclose Pharmaceutical Stocks - The New York Times

The Readout

Damian Garde & Meghana Keshavan

Moncef Slaoui wakes up at 2:30 a.m.

That’s among the details the former GlaxoSmithKline executive divulges on his work leading Operation Warp Speed in a podcast interview with the Department of Health and Human Services’ head of public affairs.

The conversation delves into the workings of Warp Speed, a pan-agency effort to speed up the development of treatments and vaccines for Covid-19, before turning into media criticism. HHS's Michael Caputo, erstwhile food photographer and podcast host, says “I'm convinced that the reporters don't want a vaccine, sir,” and Slaoui explains that he was personally offended by a July 15 New York Times story pointing out that he is not required to make routine ethics disclosures or divest any of his stock in companies working on Covid-19, a potential conflict of interest. And then things took a turn.

“If I had the possibility, I would like someday to sit down with the journalist that wrote that, and look at that person in the face, and ask that person, ‘I know what I have been doing for now 10 weeks in this role, day and night. I know what I'm doing every day to try and help all the population, including you journalists. What have you been doing?’” Slaoui said.

I Was Wrong: We Can’t Skip Phase 3 Vaccine Trials

I Was Wrong: We Can’t Skip Phase 3 Vaccine Trials

The Readout

Damian Garde & Meghana Keshavan

Warp speed is fast enough

Yesterday, amid a Twitter tempest, we asked readers whether society should wait on the results of large clinical trials before distributing Covid-19 vaccines. The answer, for the majority, was yes, please.

About 61% of respondents said Phase 3 data are key to understanding whether a vaccine actually works, and any widespread use should come only after studies are complete. The remaining 39% embraced thinking outside the box in light of Covid-19’s disastrous effects on health and society.

This may seem fairly obvious — clinical trials determine whether medicines work — but there are some prominent proponents of cutting corners when it comes to Covid-19 vaccines. Among them was Stephen Salzberg, a professor of biomedical engineering at Johns Hopkins whose editorial urging immediate vaccination blew up on Twitter over the weekend, finding at least some defenders and many more critics. It’s worth noting that Salzberg’s follow-up piece is titled “I Was Wrong: We Can’t Skip Phase 3 Vaccine Trials.”