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)

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