Authors

Sravya Chary is a manager in the pharmaceutical industry, a Master of Bioethics (MBE) candidate at Harvard Medical School, and a Petrie-Flom student fellow for the 2020-2021 academic year.
Illustration of fetus, DNA, lab supplies

Assisted Reproductive Technologies: A Bioethical Argument for Medicaid Coverage

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By Sravya Chary

Assisted reproductive technologies (ARTs) such as artificial insemination, egg retrieval, and in-vitro fertilization (IVF) have revolutionized the landscape for people facing reproductive obstacles. Disappointingly, none of these technologies are covered under Medicaid — an insurance program for low-income adults and children, and people with qualifying disabilities.

Given the high prices of ARTs, those on Medicaid, which includes a disproportionate number of BIPOC individuals, are left behind in sharing the benefits of advancements in reproductive technologies. It is vital for ARTs to be covered under Medicaid to uphold reproductive justice and autonomy for this patient population.

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gavel on top of a pile of bills and pills

Federal Court Halts Implementation of 340B Dispute Resolution Rule

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By Sravya Chary

The U.S. District Court for the Southern District of Indiana’s recent decision to grant Eli Lilly’s motion for a preliminary injunction rightfully halted the implementation of a dispute resolution rule for the 340B Drug Pricing Program.

The Alternate Dispute Resolution Final Rule (“ADR Final Rule”), issued on December 10, 2020, attempted to settle oft-occurring battles between pharmaceutical manufacturers and 340B covered entities. A few weeks later, the Department of Health and Human Services (HHS) released a 340B advisory opinion defining the department’s understanding of the statute.

The 340B Drug Pricing Program was established by Congress in 1992 with the intent to stretch federal resources to serve the nation’s most vulnerable patients. In practice, however, the program has deviated from its original intent.

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America divided concept, american flag on cracked background.

The Health Implications of Xenophobia Directed Toward Asian Americans

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By Sravya Chary

In response to the March 16, 2021 attacks targeting spas in Atlanta, GA that resulted in the deaths of eight individuals, six of whom were Asian women, President Biden urged Congress to pass the COVID-19 Hate Crimes Act.

The legislation was first introduced nearly a year ago, on May 5, 2020, but did not receive a congressional vote at that time.

The COVID-19 Hate Crimes Act, although beneficial as a reactive solution to hate crimes, does little to mitigate the long-term negative health implications of xenophobia on Asian Americans.

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Hundred dollar bills rolled up in a pill bottle

Ensuring 340B Discounts Trickle Down to Low-Income Patients

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By Sravya Chary

The 340B prescription drug program was created with the original intent of providing discounted drugs to vulnerable patients. However, this program inadvertently created a revenue stream for for-profit retail pharmacies and intermediaries, which is cutting into the benefit received by low-income patients.

In a previous blog post, I discussed the pitfalls of a recent 340B advisory opinion released by the Department of Health and Human Services (HHS). The aim of this opinion was to provide more clarity regarding contract pharmacy use within the 340B program. However, the opinion ultimately did not alleviate the tension between pharmaceutical manufacturers and 340B representatives.

As one facet of a long-term solution to this ongoing issue, I proposed further investigation of 340B savings to analyze whether discounts are truly trickling down to vulnerable, low-income patients.

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Pill pack.

HHS’s 340B Advisory Opinion: Helpful or Harmful?

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By Sravya Chary

A recent advisory opinion released by the Department of Health and Human Services (HHS) left many 340B advocates hungry for answers and pharmaceutical manufacturers frustrated.

The 340B program discounts the price of drugs paid by safety net hospitals to pharmaceutical manufacturers. The program is of critical importance to low-income and uninsured patients, especially during the COVID-19 pandemic.

HHS should take timely measures to resolve the concerns raised by the advisory opinion and resume the free flow of 340B discounted drugs to vulnerable patients.

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Vial and syringe.

Challenges in COVID-19 Vaccine Rollout: Lessons from the UK

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By Sravya Chary

Just over a week after the United Kingdom became the first Western country to authorize the COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the U.S. Food and Drug Administration (FDA) followed suit on December 11, 2020.

This lag may prove beneficial. The United States can and should cautiously assess the United Kingdom’s vaccination strategy to avoid challenges that may impede its ability to control the virus.

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Vaccine.

Benefits and Drawbacks of Emergency Use Authorizations for COVID Vaccines

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By Sravya Chary

Two COVID-19 vaccine manufacturers recently submitted Emergency Use Authorization (EUA) requests to the Food and Drug Administration (FDA) for their candidates.

While the need for a safe and efficacious COVID-19 vaccine is dire and immediate, an EUA may not be the best regulatory method to provide access. Experts warn that the EUA pathway may impede vital scientific progress needed to establish the long term safety and efficacy of investigational COVID-19 vaccines.

According to the FDA, an Emergency Use Authorization is a tool that allows an unapproved medical product to be released to the public in a health crisis given that the medical product meets statutory criteria outlined in Section 564 of the Federal Food, Drug, and Cosmetic Act.

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pills

Cuts to 340B Drug Reimbursement May be Harmful During COVID-19

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By Sravya Chary

On October 19, 2020, the U.S. Court of Appeals for the District of Columbia decided not to revisit two rulings that upheld Medicare reimbursement cuts for hospitals that participate in the 340B program.

The 340B program provides drugs at discounted prices to hospitals that primarily help under-served populations. Slashing Medicare reimbursement for safety-net hospitals that participate in the program may have devastating effects on the individuals who rely on these hospitals for discounted drugs and care, especially during the COVID-19 pandemic.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Experts Question FDA Approval of Remdesivir for COVID-19

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By Sravya Chary

Experts are calling into question the recent decision of the U.S. Food and Drug Administration (FDA) to approve remdesivir (sold under the brand name Veklury) for the treatment of COVID-19 and casting scrutiny as to whether the decision is truly in the public’s interest.

Evaluating and approving an effective treatment for SARS-CoV-2 virus has been a top priority for regulatory authorities, especially in the absence of a viable vaccine. On October 22, 2020, the FDA approved Veklury for the treatment of COVID-19 in adult and pediatric patients requiring hospitalization.

The FDA cited three randomized, controlled clinical trials as the evidence supporting its decision to approve Veklury. The findings from the three studies were as follows: first, that the median time to recovery from COVID-19 was 5 days sooner in the Veklury group compared to the placebo group. Second, that the odds of a research subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day treatment group than the standard of care group (the 10-day treatment group did not show a statistically significant difference from the standard of care group). Third, that there were no statistically significant differences in recovery or mortality rates between subjects in the five-day Veklury group versus the ten-day Veklury group.

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Duplicate Discounts Threaten the 340B Program During COVID-19

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By Sravya Chary

The 340B program, which provides discount drugs to safety-net hospitals, faces an uncertain future due to revenue leakage faced by pharmaceutical manufacturers and increased demand spurred by the COVID-19 pandemic.

Over the last few months, growing demand for 340B drugs and hard-to-monitor billing issues have placed an immense and unforeseen financial burden on pharmaceutical manufacturers. In response, some pharmaceutical manufacturers have threatened to withhold 340B drugs from contract pharmacies, thus limiting access to steeply discounted drugs for eligible patients.

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