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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John Quincy Adams’ Tips for a Safe Summer

Hot Topics | July 30th, 2021

President John Quincy Adams was an avid swimmer and was known to start his days with an early morning dip in the water. Though he was a proficient swimmer, Adams had a brush with death the morning of June 13, 1825. On that particular day, Adams spied an abandoned boat and decided to row it down Tiber Creek, across the Potomac and swim back. However, by the time Adams reached the Potomac, the boat was taking on water and was about to capsize. Adams jumped overboard wearing all of his clothes. In his diary, Adams described his shirt sleeves as “two fifty-six pound weights upon my arms” that were pulling him underwater.

Luckily, the president never swam alone and his steward Antoine Michel Guista had already stripped off his clothes (as was customary for swimmers in the early 19^th century). Unencumbered by his garb, Guista was able to pull Adams to shore and save his life.

As you prepare to don your swim trunks for the weekend, remember to:

• Leave your waistcoat and pantaloons at home. Wear a life jacket on the water instead
• Always swim with a buddy
• Never commandeer an abandoned boat

And before you head to the water to catch some rays, catch up with us on the healthcare public policy news that was making headlines this week:

In it for the long haul

• On Monday, the White House issued new guidance specifying long-term symptoms of COVID-19 (a.k.a. “long COVID-19”) may qualify as a disability under the Americans with Disabilities Act. The guidance specifies that an individualized assessment is needed to determine whether or not an individual’s long COVID-19 symptoms qualify as a disability. (Axios, POLITICO, The Hill)

Masks are back, back again

• The Centers for Disease Control and Prevention (CDC) issued new guidance on Tuesday recommending that vaccinated Americans living in areas of “high” or “substantial” transmission of COVID-19 should resume wearing masks indoors. Driving the new guidance is data from other countries that suggest fully vaccinated individuals infected with the Delta variant of COVID-19 may be contagious. (Roll Call, Axios, POLITICO)

Vaccine requirements proliferate

• Faced with rising case numbers fueled by the Delta variant of COVID-19, health systems, private businesses and the federal government are exploring, and in many cases implementing, vaccination requirements. (Axios) This week the Veteran’s Administration (VA) became the first federal agency to require its employees to be vaccinated. President Biden is also exploring the possibility of requiring all federal workers receive a COVID-19 vaccine. (The Hill)

Investigation in CDC interference expands

• House Democrats expanded their investigation into political interference at the CDC during the Trump administration. At the heart of the inquiry is whether Trump administration officials meddled in the CDC’s Morbidity and Mortality Weekly Reports, which include published scientific data. The expanded inquiry is now requesting interviews with former CDC officials including Nancy Messonnier, who held several public-facing roles throughout 2020. (The Hill, The Washington Post)

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.

You’re Going to Want to Sit Down for This One 

Hot Topics | July 23rd, 2021

Washington D.C. may not have the tallest buildings nor the largest population in the United States, but the nation’s capital is home to a landmark that was once the world’s largest chair. Standing at 19.5 feet tall, the “Big Chair” sits at the corner of Martin Luther King Avenue and V Street SE on the eastern bank of the Anacostia River.

The oversized home furnishing was built as a marketing ploy by Curtis Brothers Furniture in 1959 to distinguish their company in the hyper-competitive furniture market. After securing the title of world’s largest chair, the Curtis Brothers pushed for even more publicity: During the summer of 1960, the seat was transformed into a 10 foot by 10 foot glass house complete with a balcony. 21-year old Washingtonian Lynn Arnold then lived in (or rather on) the Big Chair for 42 days.

Although the Big Chair no longer holds the title of world’s largest chair, it endures as an unmistakable landmark and symbol of resilience in a Washington D.C. neighborhood that has historically faced economic hardship and underinvestment. 

We invite you to sit back in your (regular) chair and catch up with the healthcare public policy news that was making headlines this week:

Medical meeting messaging to go under FDA’s microscope

• The Food and Drug Administration (FDA) announced it will conduct a study to determine the extent to which industry messaging at medical meetings is false and misleading. When justifying the study, the FDA pointed to data showing that at least 80% of physicians attend at least one medical meeting per year and spend an average of seven hours on the exhibit floor at each event. The study itself will focus on three topics: advertising features, target populations and research quality. (STAT)

And you thought your plate was full

• Following a pause induced by the COVID-19 pandemic, the FDA announced it would resume routine inspections of domestic biopharmaceutical manufacturing facilities. The regulator has a backlog of more than 8,000 “non-mission-critical” surveillance inspections. The backlog has delayed approximately 68 New Drug Applications due to the agency’s inability to conduct pre-approval, pre-market or pre-license inspections. (Endpoints News)

Mask madness

• On Sunday, Surgeon General Dr. Vivek Murthy hit the airwaves to defend the decision of the Centers for Disease Control and Prevention (CDC) to lift mask guidance for vaccinated individuals as COVID-19 cases rise across the country. (The Hill) However, Murthy also caveated that he supports individual counties, such as Los Angeles County, who wish to reinstate mask mandates to combat local surges in infection. (The Washington Post) The reimposition of local mask mandates comes as the White House has begun to mull a fresh push for nationwide mask guidance. Talks are still in early stages, and it is not yet clear what this push might look like. (The Washington Post)

At the intersection of infrastructure and drug pricing

• Democrats are continuing to target the repeal of a Trump-era regulation on drug rebates as a means for funding infrastructure spending in Washington. The regulation in question would lower out-of-pocket costs for some consumers, but it would also increase Medicare premiums costing the federal government an estimated $177 billion over ten years. Insurers and pharmacy benefit managers stand to gain the most from the repeal of the regulation, while pharmaceutical companies are pushing for the rule to stay in place. (Axios)

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Where the City Ends: At the Frontier of the District of Columbia

Hot Topics | July 16th, 2021

The oldest federal monument in the country is not a stately building nor a grand memorial. Rather, the oldest federal monument(s) in the United States are the humble boundary stones that ring the District of Columbia.

Once President Washington chose Jones Point, Alexandria, as the southernmost point of the District of Columbia, the hard work of demarcating the boundaries of the new federal district fell to Major Andrew Ellicott, Benjamin Banneker and a team of other surveyors. Starting at Jones Point, the men embarked on a forty-mile journey to survey the four, ten-mile sides of the District of Columbia. (From 1791 until 1846 when land west of the Potomac was returned to Virginia, the District of Columbia was shaped like a rhombus.) With the boundaries surveyed, 20 feet of land was cleared on each side of the border and 40 sandstone boundary markers were placed around the perimeter of the District of Columbia at one-mile intervals.

Today 36 of the original 40 stones are still standing along highways, in parks, behind private residences and next to businesses. Though perhaps a relic of a bygone era in the age of GPS, the boundary stones continue to inform wanders and explorers whether they are in the District of Columbia, Maryland or Virginia. 

With this knowledge you could go on a ~60 mile tour of the boundary stones like this guy did in May 2020, or you can stick with us and catch up on the latest healthcare public policy news:

 Pricing policy at the stroke of the president’s pen

• Last Friday, President Biden signed a broad executive order that aims to lower drug prices by: 1.) Ordering the Department of Health and Human Services to develop a “comprehensive” plan to lower drug prices within 45 days 2.) Allowing a Trump-era policy on the importation of drugs from Canada to stand and 3.) Pausing a rule that would prevent the government from using the 1980 Bayh-Dole Act to lower drug prices. (STAT) Known as “march-in rights,” the Bayh-Dole Act allows a government agency that funds private research to require a company to license its patents if the needs of the public’s health are not “reasonably satisfied” and if a medicine is not available on “reasonable terms.” (STAT)
  • Read more: Who is going to write President Biden’s drug pricing plan? (STAT)

Drug pricing wheeling and dealing in the Senate

• Some Senate Democrats want to lower drug prices to help pay for a massive $3.5 trillion partisan spending bill that would enact many of the party’s legislative priorities from child care to climate change. Though details are vague, draft legislation does include a provision repealing a Trump-era policy that eliminates drug rebates between pharmacy benefit managers and insurance companies. Democrats are also discussing the prospect of allowing Medicare to negotiate drug prices. Expect more details to emerge in the coming weeks as details are finalized. (STAT, Axios, The Hill

Medicare for more than just medical care

• Democrats have agreed on one provision of their proposed $3.5 trillion spending bill: expanding Medicare to include coverage for dental, vision and hearing care. Currently the traditional Medicare program, which covers about 75% of senior citizens, provides only limited coverage for these services. The Congressional Budget Office estimates this policy would cost the federal government $358 billion over the next decade, and some centrist senators including Joe Manchin (D-W. Va.) are questioning how the policy will be paid for. (The Washington Post, The Hill, Axios)

 FDA cracks down on marketing malpractice

• The Food and Drug Administration (FDA) issued a stern letter to Amgen after the company released an advertisement for Neulasta, a bone marrow stimulant, that cited a study purporting a statistically significant higher risk of developing febrile neutropenia when using a pre-filled syringe versus an injector. Amgen markets the “OnPro” injector kit which was promoted in the advertisement. The FDA’s letter said the study had “multiple limitations” and the ad was “concerning from a public health perspective.” (STAT)

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The Sights of a Summertime Stroll

Hot Topics | July 9th, 2021

Summer is a great time for a stroll around our nation’s capital. And while you’re out and about, you’ll likely come across one of D.C.’s 100 public murals tucked among the stately buildings and grand monuments. In 2007 the city’s Department of Public Works created MuralsDC to promote the creation of these murals with the goals of teaching art to teenagers, deterring graffiti and revitalizing neighborhoods. While Washington may not be the only city with a public arts program, many of D.C.’s murals tell a unique local story. Take Lee’s Legacy Mural on U Street NW, a tribute to Lee’s Flower and Card Shop which has been serving Washingtonians since 1945. Other murals such as Black Lives Matter Plaza speak to the city’s inextricable links to national social and political issues.

Here are the updates at the intersection of political and healthcare issues about which you should know:

Delta signals change

• With the number of new doses of COVID-19 vaccines administered each day in free fall, the White House is continuing to push a more targeted approach in the fight against COVID-19. (Axios) On Tuesday, President Biden all but begged Americans to get vaccinated. He also explained the steps his administration is taking to keep the vaccination campaign going, which include directing more doses to doctors and pediatricians. The federal government will also deploy “surge response teams” to help local officials mitigate outbreaks in areas of the country with low vaccination rates. (The Hill)

Old school vs. new school

• A lobbying battle is heating up in Washington between two unlikely adversaries: the pharmaceutical industry and the paper industry. At issue is an obscure provision tucked into the Food and Drug Administration’s (FDA) funding bill that prevents the agency from digitizing prescription information. Since the FDA issued a proposal in 2015 that would require drug makers to provide some prescribing information digitally, the paper industry has lobbied Congress to prevent the proposed rule from going into effect. If the rider preventing the rule were rescinded, the FDA’s proposal would save 90 billion sheets of paper each year. (The Hill)

House releases report on research and revenue

• On Thursday, the House Oversight and Reform Committee issued a report claiming that 14 pharmaceutical companies spent more on stock buybacks and dividends ($577 billion) than research and development ($521 billion) from 2016 to 2020. The release of the report comes as House Democrats continue working to build support for their H.R. 3 bill, which would empower the Secretary of Health and Human Services to negotiate lower drug prices. (The Hill)

Pfizer wants to cover your OOPs

• Last year Pfizer sued the Department of Health and Human Services arguing rules preventing the company from covering patients’ out-of-pocket (OOP) drug costs were unconstitutional. A federal judge is expected to issue a ruling soon, which could have sweeping implications for how much taxpayers will pay in Medicare drug costs. Supporters of the government’s position argue that a ruling in Pfizer’s favor would encourage patients to use expensive drugs by eliminating all cost-sharing. (Axios)

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.