One of Washington’s coolest museums

Hot Topics | August 27th, 2021

Are you hungry for some culture? You could head to the National Mall and visit one of the Smithsonian museums, or you could head to The Fridge (capital “T” capital “F”). Located in Southeastern D.C.’s Capitol Hill neighborhood, The Fridge is a gallery specializing in street art. Before you can visit The Fridge, you first have to find it. The museum is located at 516 ½ 8^th Street SE, which is halfway down a back alley. You’ll know you’re in the right place if the alley is covered in wall-to-wall street art. Once you’ve located The Fridge, you’ll find exhibitions such as a street art sticker show.

Finding The Fridge might not be easy, but you’re exactly where you want to be if you’re looking for the healthcare public policy stories that were making headlines this week:

Pfinally approved

• The Food and Drug Administration (FDA) granted full approval to Pfizer’s COVID-19 vaccine (Comirnaty) in people aged 16 or older on Monday. The approval came about nine months after the FDA granted the shot Emergency Use Authorization (EUA). Public officials are hopeful the full approval will help persuade unvaccinated Americans to get vaccinated. (FDA, STAT, POLITICO, Roll Call)

A multitude of mandates are materializing

• A new wave of vaccine mandates came crashing down on the heels of Comirnaty’s approval. Public sector employees including New York City public school employees and all services members under the Department of Defense are now required to be vaccinated. (Axios, The Hill) The American Medical Association also issued a formal recommendation that both the public and private sectors mandate COVID-19 vaccinations. (The Hill)

How low will guidelines go?

• Revised screening guidelines are recommending that Americans be screened for certain diseases at ever younger ages. Under new recommendations from the U.S. Preventative Services Task Force (USPSTF) issued earlier this week, Americans should now be screened for Type 2 diabetes starting at age 35. (Axios) Earlier this year, the USPSTF issued updated screening guidelines which lowered the age at which certain Americans should be screened for lung cancer. For a quick refresher, check out our newsletter from March 12.

Doubling down on drug pricing reform FTW

• The White House is going all-in on drug pricing reform as it seeks to help shepherd a $3.5 trillion reconciliation bill through Congress. Officials in the Biden Administration are touting the popularity of a proposal that would allow Medicare to negotiate prescription drug prices to help ensure Democrats fall in line behind the larger bill. With the White House confronting a number of policy challenges from Afghanistan to COVID-19, drug pricing reform is seen as an issue that can help shore up support for Democrats who are running for re-election in 2022. (POLITICO)

If you enjoyed this week’s excerpt from Policy News from Goodfuse, we invite you to email us at [email protected] to sign up for the full weekly “insider only” newsletter featuring fun-to-read round-ups of Hot Topics, breaking news and some quirky facts to make your Fridays Goodfused.

Where Washingtonians go for Afternoon Delight

Hot Topics | August 20th, 2021

The story of Washington, D.C. singing/songwriting duo Taffy Nivert and Bill Danoff does not end in 1970 after they composed “Take Me Home, Country Roads.” (Read our last edition of Policy News for that tale.) A few years later Nivert and Danoff formed the Starland Vocal Band, which cult fans of 70’s pop music may know from their single “Afternoon Delight.” In this week’s edition of Policy News, we share the decidedly D.C. (and safe for work) origins of everyone’s favorite song about a midday tryst.

The year was 1974, and Bill was dining with friend and fellow Starland member Margot Chapman at Clyde’s restaurant in Georgetown. The two were having a late lunch, and Bill noticed that Clyde’s was serving a menu from three to six called “Afternoon Delights.” After having his fill of spiced shrimp and hot Brie with almonds, Bill went to visit Taffy who was recovering from a cervical cancer operation to explain that he was going to write a song about what afternoon delight “should be.” The song would go on to top the charts in 1976, although as Taffy would later joke: “The song was huge but no one could remember the name of the group!”

And now for this week’s healthcare public policy news, which we hope you’ll find interesting, if not delightful:

Big news on boosters

• Amid rising infections from the Delta variant of COVID-19, the White House’s most senior health advisors announced on Wednesday that booster shots will be recommended for all Americans eight months after their last dose. The White House would like to begin offering booster shots the week of September 20^th, though timing is subject to the Food and Drug Administration’s (FDA) review of clinical trial data and a recommendation from the Centers for Disease Control and Prevention (CDC). (Roll Call, Axios, The Hill)
  • Read more: This decision from the White House is not without its critics. A number of scientists and public policy experts have spoken out against the plan to offer Americans COVID-19 booster shots. (STAT)

A mandate that will impact millions

• Also on Wednesday, President Biden announced that the approximately 1.3 million workers employed by nursing homes will be required to get vaccinated against COVID-19. Facilities whose workers are not fully vaccinated will have Medicare and Medicaid funding withheld. (The Hill, Axios) Associations representing providers were cool to the idea, expressing concern that the mandate would worsen staff shortages in the industry. (The Washington Post – full text below)

The tussle over drug price transparency

• The U.S. Chamber of Commerce and the Pharmaceutical Care Management Association (representing the country’s pharmacy benefit managers) have filed a lawsuit against the federal government to stop a Trump-era regulation that would require the disclosure of prices for drugs and medical services. The lawsuit argues the regulation is illegal because of a change made to the proposed regulation that was incorporated into the final rule, as well as a potential conflict with an existing federal law. (Axios)

FDA Faces

• Former FDA Commissioner Dr. Stephen Hahn gave an interview to the Associated Press (AP) where he advocated for additional safeguards to protect the agency from political interference. (AP – Washington Bureau)
• Bloomberg reported that Acting FDA Commissioner Dr. Janet Woodcock is no longer under consideration to lead the agency permanently. (Bloomberg – full text below)
• Ellis Unger, the long-time head of the Office of Drug Evaluation-I, has announced he will retire after 25 years at the agency. (STAT – full text below)

If you enjoyed this week’s excerpt from Policy News from Goodfuse, we invite you to email us at [email protected] to sign up for the full weekly “insider only” newsletter featuring fun-to-read round-ups of Hot Topics, breaking news and some quirky facts to make your Fridays Goodfused.

 

Take Me Home, District of Columbia Roads

Hot Topics | August 6th, 2021

This week we have a story that all the mountain mamas out there might find unsettling: While the lyrics of John Denver’s hit “Take Me Home, Country Roads” may conjure up images of a scenic drive along winding rivers and rolling hills, the inspiration for this platinum single came not from a country road in West Virginia, but Clopper Road off Interstate 270 in a suburb of Washington, D.C.

In 1970, D.C. songwriters Bill Danoff and Taffy Nivert were driving to a family reunion along winding roads in Gaithersburg, Maryland. To pass the time, the couple started composing lyrics for a song they envisioned for Johnny Cash. According to fellow songwriter Lee Jaffe, the opening lyric of the song was originally “Almost heaven, Massachusetts.” However, Danoff and Nivert didn’t “like the vibe,” and changed the state to West Virginia. At the time, neither Danoff nor Nivert had ever set foot in West Virginia! 

On the evening of December 29, 1970, Danoff and Nivert shared their partially-written song with John Denver, who first performed the song at the Cellar Door in Georgetown the following night. Denver then went on to record the song the following January with Nivert and Danoff on backing vocals.

And now let us take you (home) to this week’s healthcare public policy news:

FDA to face inquiry from federal watchdog

• The Health and Human Services Office of the Inspector General will launch an investigation into the Accelerated Approval pathway that was used to approve Biogen’s Alzheimer’s treatment Aduhelm (aducanumab). The inquiry will look at a Biogen initiative called “Project Onyx” that sought to convince Food and Drug Administration (FDA) officials to approve Aduhelm despite questions over the company’s clinical trial data. (STAT, Endpoints News)

Lobbyists place ARPA-H in their crosshairs

• The proposed Advanced Research Projects Agency for Health (ARPA-H) has spurred a flurry of lobbying activity in Washington. Though it is not yet certain that the agency will be created, patient advocacy groups are jockeying to ensure their constituents would benefit if the agency comes to fruition. Pharmaceutical and biotechnology companies may also benefit from the agency, which would be in a position to award much of its funding to the private sector. (STAT)

Accelerating the approval timeline

• Amid rising case numbers and hospitalizations fueled by the Delta variant of COVID-19, the FDA announced it would deprioritize some of its existing work to throw more resources behind its review of Pfizer’s application for the formal approval of its COVID-19 vaccine. Health experts have urged the FDA to accelerate its review of the application, as the full approval might sway more Americans to get the jab. The agency now aims to complete its review of the application around September. (STAT, POLITICO)

The skinny on the fate of “skinny labels”

• A federal appeals court panel has issued a ruling that may make it more difficult for generic drug makers to “carve out” indications and offer Americans cheaper alternatives to brand name drugs. For decades, the Hatch-Waxman Act has allowed generic drug manufactures to obtain approval for specific uses that are not covered by a brand name drug’s patent. The ruling from the appeals court is expected to “make it harder for generics and biosimilars manufacturers, in good faith, to carve out infringing uses of their products from their product labels.” (STAT – full text below)

If you enjoyed this week’s excerpt from Policy News from Goodfuse, we invite you to email us at [email protected] to sign up for the full weekly “insider only” newsletter featuring fun-to-read round-ups of Hot Topics, breaking news and some quirky facts to make your Fridays Goodfused.