FDA

What Happened, What You Missed: March 27-31, 2023 

by Katelyn Crume

FDA Allows Narcan to Be Sold Over the Counter 

On Wednesday, the Food and Drug Administration (FDA) approved Narcan, an opioid overdose-reversal drug, to be sold over the counter without a prescription. The announcement comes as opioid overdose deaths hover near record highs.  At a press conference, the Director of the White House Office of National Drug Control Rahul Gupta said businesses, such as restaurants, banks, and schools will be encouraged to purchase the drug. Narcan manufacturer Emergent BioSolutions said the spray will be available for online and over the counter purchase by the summer. 

JAMA: Telehealth Linked to Fewer Opioid Overdoses 

A study published in the Journal of the American Medical Association (JAMA), found that the utilization of telehealth services for opioid use disorder during the COVID-19 pandemic reduced the odds for a fatal overdose among Medicare beneficiaries. The study determined that beneficiaries who started treatment during the pandemic and received telehealth services had a 33% lower risk of a fatal overdose. The study also found that fatal drug overdoses were 59% less likely among individuals who received medication to treat opioid use disorder and 38% less likely among those treated with buprenorphine in an office-based setting. 

FDA Proposes Overhaul of Fast-Track Approval Process for Cancer Drugs 

The FDA’s accelerated approval pathway could become more stringent, according to a draft guidance document released Tuesday. The accelerated approval pathway allows the FDA to approve a drug based on surrogate endpoints rather than a direct measure of a clinical benefit, which allows for drugs to receive an earlier approval. The draft guidance aims to strike a balance between speed and quality by requiring oncology drugs to go through randomized controlled trials (RTCs) that compare the effectiveness of an experimental drug against a conventional one.  The deadline for stakeholders to comment on the draft guidance is May 26, 2023. 

Lawmakers Question Becerra on Coverage Determination for Alzheimer’s Drug 

In multiple hearings to review the president’s proposed Fiscal Year (FY) 2024 budget, several Republican lawmakers voiced their criticism of a decision by the Centers for Medicare and Medicaid Services (CMS) to limit coverage of a class of Alzheimer’s drugs only to patients who are participating in relevant clinical trials. These drugs, which utilize amyloid plaque-blocking technology, have been marred with controversy due to their high cost and risk of side effects such as brain swelling and brain bleeding.  In response to the criticism, Health and Human Services Secretary Xavier Becerra repeatedly explained that FDA and CMS have different criteria for evaluating experimental drugs as mandated by law. 

Most Doctors Say COVID-19 Misinformation a Problem 

Seven in 10 doctors say misinformation about COVID-19 has made it harder to treat patients, according to a poll by the de Beaumont Foundation and Morning Consult.  A similar number of physicians surveyed said misinformation has negatively impacted patient outcomes.  The survey also found that 90% of physicians surveyed agreed on the benefits of COVID-19 vaccines.  Most doctors also noted that COVID-19 misinformation has seeped into other areas of health care, with two-thirds saying misinformation is common regarding weight loss, dietary supplements, mental health, and other vaccines. 

Former Congressional Aide Launches Union Tracker for Senate Staff 

A former member of Minnesota Sen. Tina Smith’s staff launched a Senate Union Tracker earlier this month as a way to track which senators support collective bargaining protections for Senate staff and efforts to unionize among their own staff. Motivated by subpar pay and long hours during his time in the Senate, the former staffer hopes the tracker will help improve working conditions for those still working in the Senate.  Since the website launch, over a dozen Democrats have favorably voiced their support for unionization in the tracker.   

Advocacy

Andy Franke Reflects on Time On and Off the Hill

by Katelyn Crume

What are some of the highlights of your career?

When I got out of law school, I wanted to focus on health policy, so I took a big chance and got an internship on Capitol Hill. I was lucky enough to get my first permanent job with a member from my home state in the House of Representatives only about 8 months after I first arrived in DC. A year later, I became Congresswoman Lynn Jenkins’ (R-KS) health policy advisor, which was another major highlight. Working in Congress just generally was fun. After she announced her retirement in January 2017, I was fortunate to go work for Congressman Eric Paulsen (R-MN) – like Congresswoman Jenkins, he was another great member of the House Ways and Means Committee. I really enjoyed working with him – he had a lot of major medical device and healthcare companies headquartered in his district, which provided some great experience.

As a Hill staffer, how did you observe advocacy change over the years?

When I first started taking meetings for Congresswoman Jenkins, I had more exposure to constituents who came in to advocate for their own issues and ideas, and as I took on more responsibility, I started to meet with more prominent organizations and registered lobbyists. Over the years, because of the way legislation moved, advocacy on the Hill went from being concentrated on one-off meetings during the year to being more sustained throughout the year. When I left the Hill, because of the issue portfolio I had and the legislative landscape, I was having meetings almost every day. I also noticed that I was meeting with more established lobbyists instead of younger advocates over time.

What are some of the biggest challenges lobbyists and advocates face in 2023?

Ironically enough, the return to how it was after two or three years of virtual meetings. A lot of senior lobbyists used to be on the Hill all day long to meet in-person, but the pandemic shut that down, and they had to transition to phone and video calls. Even events like fundraisers were done through videoconferencing. Now, it’s almost back to the normal way of going to the Hill in the morning and seeing who you could meet up with off-the-record. After 3 years of not being able to do that, it’s a little bit challenging to get back into the swing of things. But it’s a welcome change, in my opinion. I really like the fact that you can finally go back to the Hill and walk in the building as a normal person without the need for an escort – you can just make an appointment, go to the Hill, and after your meeting is done, go back to the Longworth café, or Cups.

What’s some of the best advice you’ve received?

A good friend and mentor who’s been lobbying for 25 years told me that if you go up to the Capitol and you don’t get a tingling feeling, then it’s time to hang it up and move on, because once you don’t get that feeling anymore, your job probably won’t be fulfilling. But if you continue to get that feeling, and you stay excited about your job, you’re going to be good at your job, whether it’s a Hill staffer, lobbyist, or advocacy professional. I think about that a lot, and I make sure that I still get the feeling that I’m happy to be there and I’m fortunate to be able to do this in the Capitol of the United States. Not many people get this opportunity.

Other that health care, what other policy areas are you passionate about?

For the 4 years that I lobbied for Zimmer Biomet, I was the go-to tax lobbyist. That was not an issue I handled in Congress, so it was a steep learning curve. At first, I did not enjoy tax policy – it’s incredibly weedy, maybe more so than health care. It took a while, but I made great relationships during the learning process. And like health care, it never seems to go away.

What else should we know about you?

I’m an avid golfer. I try to get better every time I play. I picked up golf in 2019 and worked on my game during the pandemic. I’ve also been married for seven years now, and I have two sons – one was just born a month ago, and I recently moved out to Virginia from DC. We lived in DC for 8 years, and we’re loving it out here in Virginia – there’s more space, and it’s a great place to raise a family. Life is good.

Drugs

What Happened, What You Missed: March 20-24, 2023 

by Katelyn Crume

NIH Rejects March-In Rights Petition for Pricey Prostate Cancer Drug 

The National Institutes of Health (NIH) rejected a petition to force drugmakers Pfizer and Astellas to lower the price of their prostate cancer drug Xtandi using its “march-in” authority, according to a letter the agency sent to the petitioners on Tuesday. March-in rights, which have never been used before, allow the federal government to forcibly relicense a patent that resulted from any amount of federal funding if an original patent holder does not make the product available to the public on reasonable terms. According to the letter, NIH declined the petition because Xtandi is already widely available, and the agency also noted that a lengthy administrative process and remaining patent life would render authorization of march-in right an ineffective means of lowering the drug’s cost. The same day, the federal government also announced an interagency effort to review the criteria used for determining march-in rights. 

Administration Proposes Major Changes to Organ Transplantation System 

On Wednesday, the Health Resources and Services Administration (HRSA) announced a new initiative to break up the private nonprofit overseeing the Organ Procurement and Transplantation Network (OPTN) by seeking more contracts to operate the system.  In a statement, HRSA said the move is intended to bring more accountability and transparency to the OPTN.  The announcement follows years of bipartisan scrutiny of the United Network for Organ Sharing (UNOS), which holds the sole federal contract to oversee the country’s organ procurement organizations and transplant centers.  HRSA also called on Congress to more than double annual program funding to $67 million, remove the appropriations cap on OPTN contracts, and expand the scope of eligible contractors.   

Biden Signs Bill to Release DOE’s COVID-19 Origin Report 

President Joe Biden signed legislation earlier this week to require the Office of the Director of National Intelligence to declassify information within 90 days on any possible links between a lab in China and the origins of the COVID-19 pandemic. However, US intelligence agencies will still retain the right to redact information to protect sources and methods. The push to enact legislation to release classified information on the origins of the pandemic comes after the Energy Department concluded with “low confidence” that the virus is likely the result of an accidental laboratory leak at the Wuhan Institute of Virology. Of note, the US intelligence community is split about the origin of COVID-19.  

FDA Panel Sends Mixed Message About Biogen’s ALS Drug  

A Food and Drug Administration (FDA) advisory panel voted against recommending full approval of Biogen’s experimental amyotrophic lateral sclerosis (ALS) drug for a rare and aggressive form of the disease.  However, the panel voted unanimously to support “conditional accelerated approval” of the drug since the data suggests the drug could be effective in reducing a protein that is associated with disease severity. Conditional accelerated approval allows for faster approval of drugs for serious conditions that fill an unmet medical need. The agency will make a final decision on the drug by April 25th. 

North Carolina Poised to Expand Medicaid  

North Carolina Governor Roy Cooper (D) is expected to sign legislation to expand Medicaid coverage for hundreds of thousands of residents into law in the coming days after state lawmakers gave the legislation final approval on Thursday.  This makes North Carolina the latest state with a Republican-controlled legislatures that has moved to expand Medicaid after years of opposition. Voters in South Dakota approved expansion in a referendum in November, and advocates in Alabama are urging state lawmakers to take advantage of federal incentives to expand Medicaid.  There are 2.9 million traditional Medicaid enrollees in North Carolina, and advocates have estimated that expansion could help 600,000 adults. 

ICYMI: Potential Pay Cuts for Congressional Staff Sound Alarms 

Historically underpaid staffers in the House of Representatives have been earning more since the passage of the Fiscal Year (FY) 2022 omnibus, which provided the largest increase to the Members Representational Allowance (MRA) since 1996 and set a minimum salary for staffers at $45,000.  However, an agreement among House Republican leaders to cut spending to FY 2022 could lead to cuts in the MRA and reverse progress in improving staffers’ pay.  Some advocates and staffers say higher pay is essential for reducing turnover on the Hill – especially among senior staff – and ensuring that congressional staff come from more diverse socio-economic backgrounds. 

Drugs

What Happened, What You Missed: March 13-17, 2023 

by Katelyn Crume

VA to Cover Controversial New Alzheimer’s Drug 

The Department of Veterans Affairs (VA) has agreed to cover new Alzheimer’s disease drug Leqembi for patients with early-stage Alzheimer’s, making the VA the first and largest health program in the nation to cover the drug.  Developed by Biogen and Esai, the monoclonal antibody treatment is considered controversial because around one-fifth of patients who participated in a clinical trial experienced brain bleeding or brain swelling.  The Food and Drug Administration (FDA) initially approved the drug in January and has since updated its warning label to encourage physicians to warn patients of the side effects.  It appears the VA will remain the only health program to cover the drug, as the Centers for Medicare and Medicaid Services (CMS) has communicated that it wants more evidence about the effectiveness of the Leqembi before making a coverage decision. 

JAMA: Mortality Rates for Kids, Teens on the Rise 

Following years of progress against pediatric deaths, the all-cause mortality rate for people ages one to 19 years increased by about 10% each year between 2019 and 2021, according to a new study from the Journal of the American Medical Association (JAMA).  Firearms are the leading cause of death for children and adolescents, and they account for nearly half of the increase in all-cause mortality in 2020.  Drug overdoses and automobiles were the second and third leading causes of death.  To turn the tide, the study calls for the enactment of sensible firearm safety laws as well as new efforts to address social inequities, segregation, and structural racism. 

Maternal Mortality Rates Rose in 2021 

The deaths of pregnant women in the US rose last year, according to new data from the Centers for Disease Control and Prevention (CDC) as deaths of pregnant women reached a six-decade high. The report found that 1,205 people died of maternal causes in the U.S. in 2021, which represents a 40% increase from the previous year.  The report also found significant racial disparities in the maternal death rate. In 2021, the rate for Black women was 69.9 deaths per 100,000 live births, which is over two-and-a-half times the rate for White women, at 26.6 per 100,000. 

FDA Approves Pfizer’s COVID-19 Booster for Kids under 5 

The FDA authorized Pfizer’s Omicron booster shot for children under five years of age who were previously vaccinated with the company’s initial three-dose vaccine regimen.  Since December, children under five who completed two doses of Pfizer’s original vaccine have been eligible to receive the Omicron booster as their third shot, or last dose in their initial vaccination series. The FDA noted that children who received the Omicron shot as their third dose aren’t eligible for the bivalent booster right now, but they should still be protected against severe complications from COVID-19. 

KFF: Non-Profit Hospitals Had Estimated $28M Tax Exemption in 2020 

Non-profit hospitals received $28 million in tax subsidies but only provided $16 billion in charity care, according to a new analysis from the Kaiser Family Foundation (KFF).  The findings come amid questions from lawmakers over whether nonprofit hospitals provide enough benefits to their communities to justify their federal, state, and local tax exemptions.  Some non-profit hospitals have also come under scrutiny for taking aggressive steps to collect unpaid medical bills, such as suing patients over unpaid medical debt.  According to the analysis, the nearly $28 billion tax exemption is equivalent to about 43% of net income generated by nonprofit hospitals in 2020.   

ICYMI: White House Welcomes Special Visitors for St. Patrick’s Day 

Irish pubs in Washington, DC aren’t the only institutions making special plans for St. Patrick’s Day.  Today, Irish Taoiseach Leo Varadkar will meet with President Joe Biden to commemorate the 25th anniversary of the Good Friday Agreement, a peace agreement that saw the end of the Troubles in Northern Ireland.  Additionally, Irish singer and former One Director member Niall Horn will appear in a special performance at the White House today.   

Drugs

What Happened, What You Missed: February 27-March 3, 2023 

by Katelyn Crume

Eli Lilly to Cut Price of Insulin 

Drugmaker Eli Lilly will reduce prices for its most commonly prescribed insulins by 70%, according to a press release issued by the company on Wednesday.  Eli Lilly also announced that it would expand its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month.  The high price of insulin has come under increased scrutiny in recent years, as evident by President Biden’s comments on insulin prices in his most recent State of the Union address.  While Congress enacted a $35 monthly cap on insulin prices for Medicare recipients, the new law does not apply to people with diabetes that have commercial insurance coverage.  However, the impact of Eli Lilly’s reduced prices appears to be limited.  The lower prices will only apply to the drugmaker’s older insulin products, and most people who require insulin use products from other drug manufacturers like Novo Nordisk and Safoni.  At the moment, it’s unclear if other insulin manufacturers will follow suit with Eli Lilly.   

Colorectal Cancer Rates Among Young People on the Rise 

Amid an overall decline in colorectal cancer cases, the number of new colorectal cancer cases among younger Americans is growing, according to a new report from the American Cancer Society.  Adults under the age of 55 comprise about 20% of new colorectal cancers, and the report says that the portion of Americans under age 55 has increased from 11% in 1995 to 20% in 2019.  Cancer experts say the rise in colorectal cancer cases could be attributed to environmental changes and dietary habits such as high consumption of ultra-processed foods. The report also found that more people are surviving colorectal cancer, with the survival rate at least five years after diagnoses increasing from 50% in the mid-1970s to 65% in 2018.  

FDA Panel Endorses RSV Vaccines for Seniors 

A Food and Drug Administration (FDA) advisory panel voted this week to recommend respiratory syncytial virus (RSV) vaccines by Pfizer and GlaxoSmithKline (GSK) for adults ages 60 and older.  While most of the panel agreed the vaccines are effective, some members were concerned about the vaccines’ relationship with nervous system disorders like Guillain-Barré syndrome.  The FDA granted priority review status to both vaccines from Pfizer and GSK, which reduces the approval timeline by four months. The end of the review period is expected to be May 2023 for both shots.  There is currently no vaccine for RSV in either adults or children, although vaccine for infants may be available by fall 2023. 

Slotkin Announces Bid for Stabenow’s Senate Seat 

Rep. Elissa Slotkin (D-MI) announced on Monday that she’s running for the Senate seat being vacated by Sen. Debbie Stabenow (D-MI).  Her decision to run for the battleground Senate seat leaves an open House seat in a competitive district that Democrats will have to defend.  While Slotkin is the first Democrat to announce her campaign, two Republicans – Michael Hoover and Nikki Snyder – have already declared their candidacy.  First elected to Congress in 2018, Slotkin worked as a Central Intelligence Agency analyst before serving as a senior Defense Department official from 2012 to 2014.  Within 24 hours of her announcement, Slotkin’s campaign raised $1.2 million. 

ICYMI: Lawmakers Prevail over Lobbyists in Congressional Hockey Challenge 

Members of Congress triumphed over lobbyists for the fifth consecutive time in the Congressional Hockey Challenge on Wednesday night.  Due to the House being out of sessions, Reps. Tom Emmer (R-MN), Dean Phillips (D-MN) were one of the few members of Congress who played for the Lawmakers, as the majority of the team’s roster consisted of current and former congressional aids.  The match took place at the MedStar Capitals Iceplex, the Washington Capitals’ practice facility in Arlington.  Nearly all proceeds from the game are directed towards hockey related organizations like the Professional Women’s Hockey Players Association and the Fort DuPont Ice Hockey Club. 

Public Health

What Happened, What You Missed: February 20-24, 2023 

by Katelyn Crume

Multiple Problems Plague Primary Care in America 

Primary care across the nation is in a dire state, according to a new report from the Milbank Memorial Fund and the Physicians Foundation.  Among the most concerning findings is an increase in the percentage of adults who don’t have a usual source of care, and the fact that too few primary care physicians are being trained in community settings.  According to the report, a major contributing factor to these problems is inadequate investment in primary care.  For example, average spending on primary care for all insurance types declined from 6.2% in 2013 to 4.6% in 2020, which is far below average spending in other wealthy nations. 

FDA Begins Review of Babies’ RSV Vaccine 

The Food and Drug Administration (FDA) granted priority review for a vaccine to protect infants up to six months of age from respiratory syncytial virus (RSV), according to an announcement from Pfizer.  The priority review status means the agency will try to review the application within six months instead of the standard 10.  There are currently no RSV vaccines available for infants, and the FDA offers priority review for drugs that promise “significant improvements” over existing drugs.  If deemed effective, the Pfizer’s RSV vaccine could be available for infants ahead of a likely RSV season next winter. 

FDA Issues First Fines to E-Cigarette Manufacturers 

The FDA fined four electronic cigarette manufacturers over their alleged sales of unauthorized products on Wednesday, marking the first time the agency has issued civil money penalty complaints against tobacco product manufacturers for allowing products to go to market without federal approval.  According to a press release, the FDA has sent more than 550 warning letters since the start of 2021 to companies that manufacture, sell, or distribute new tobacco products without being allowed. Most of the companies that received warning letter have taken their products off the market and are now complying with FDA regulations. 

Poll: High Costs Is America’s Number 1 Public Health Worry 

Reducing high drug and health costs was the top public health priority for 50% of Americans, according to a new poll from Axios-Ipsos.  In comparison, 14% said reducing gun deaths and another 14% listed research into cures and treatment for major diseases as a top priority for government intervention.  When asked to name the number one threat to public health, over a quarter of respondents said opioids and fentanyl, 21% cited obesity, 17% listed gun violence, and 12% said cancer.  Additionally, a large majority of respondents said the country is not prepared to handle another pandemic.  The poll was conducted in February and included over 1,200 adults. 

ICYMI: Cicilline to Resign from Congress in June 

Rep. David Cicilline (D-RI) announced earlier this week that he will officially leave Congress on June 1, 2023.  A member of the Foreign Affairs and Judiciary committee, the 61-year-old Cicilline has been elected to seven terms in Congress.  Prior to entering Congress, he served in the Rhode Island state legislative and as mayor of Providence.  Cicilline is leaving to Congress to lead the Rhode Island Foundation, which supports community programs in the Ocean State through grants and investments.  His retirement will trigger a special election in the heavily Democratic 1st Congressional District. 

Administration

What Happened, What You Missed: February 13-17, 2023 

by Katelyn Crume

Administration Proposes New Medicare Drug Pricing Reforms 

On Tuesday, the Centers for Medicare and Medicaid Services (CMS) announced a trio of drug pricing proposals that would standardize how much Medicare beneficiaries pay for certain generic drugs, explore new ways for Medicaid to pay for expensive cell and gene therapies, and test ways to pay for drugs approved without a proven clinical benefit.  The proposals stem from an executive order President Biden signed last year directing the administration to develop demonstrations that would complement the drug pricing provisions of the Inflation Reduction Act. Beyond the three proposals, CMS also called for more research to encourage adoption of biosimilars, data access to support price transparency, and access to cell and gene therapies under Medicare. 

Administration Proposes Nursing Homes Disclose Connections to Private Equity 

Nursing homes would have to disclose whether private equity firms or real estate investment trusts own or help operate facilities under a proposed CMS rule released on Monday.  The rule would require nursing homes to report such relationships during the Medicare and Medicaid enrollment process, which would enable government agencies and the public to more easily determine whether nursing home owners are private equity investors or real estate investment trusts.  In response, the American Health Care Association and National Center for Assisted Living (ACHA/NCAL) called the rule a “distraction from the real issues” facing nursing homes, like the underfunding of Medicaid and workforce shortages. 

Feinstein Announces Retirement 

Sen. Dianne Feinstein (D-CA), the Senate’s oldest member, announced her retirement on Tuesday.  A former mayor of San Francisco, Feinstein announcement came amid concerns regarding her age and mental acuity.  She is the first woman to have chaired the Senate Rules Committee and the only woman to have chaired the Select Committee on Intelligence. Since the announcement, Reps. Katie Porter (D-CA) and Adam Schiff (D-CA) have both announced their plans to run for Feinstein’s Senate seat, and Rep. Barbara Lee (D-CA) is widely expected to announce her own Senate run.   

FDA Issues New Warnings on Aduhelm 

The Food and Drug Administration (FDA) recently updated the label of Biogen’s Alzheimer’s drug Aduhelm following the death of a 75-year-old woman who experienced brain bleeding and swelling while taking the drug.  The new label calls on physicians to “inform patients that events of intracerebral hemorrhage” can happen infrequently when taking Aduhelm.  According to clinical trial data, 41% of Aduhelm-treated patients experienced brain bleeding and/or swelling, compared to 10% of patients on placebo.  Aduhelm received a controversial accelerated approval from the FDA in June 2021, despite mixed data on the drug’s clinical benefit for Alzheimer’s patients.  Aduhelm sales have remained low due to the drug’s high price tag and a decision from some major university hospital systems to not prescribe the drug. 

ICYMI: UFO Fever Hits Washington…Again 

Members of Congress and the general public has once again become enamored with unidentified flying objects (UFOs) after the Pentagon admitted to shooting down three such UFOs last weekend.  Details about the recent incidents remain sparse as earlier this week, Sen. Jim Risch (R-ID) said the craft was “smaller than a car,” and that one carried “a payload.”  However, other senators have been quick to clarify that the objects are not extraterrestrial in origin.  In recent years, UFO fascination in Congress has centered around reports of unidentified ariel phenomena (UAP) from US Navy personnel.