Now that U.S. Supreme Court has overturned Roe v. Wade in Dobbs v. Jackson Women’s Health, the implications of that action will be felt by employee benefit plans and the companies that offer them. Among those implications are the logistics of how to offer coverage for employees who must travel out of state to obtain a legal abortion.

The Reed Smith Reproductive Health Working Group has generated a series of “unanswered questions” client updates to reflect the issues that a Roe reversal may have for the health care industry. Earlier posts on this blog shared the first three parts of that series that focused on pharmacies, health care providers, and fertility practices, respectively.

In Part IV of the series, Allison Warden Sizemore considers the implications of the reversal on employee benefits plans. Specifically she highlights issues arising from an employer’s offer to cover travel costs for employees who travel for an abortion.

Continue Reading <strong>Unanswered Questions for Employee Benefits Plans from Supreme Court overturn of Roe v. Wade</strong>

In an opinion authored by Justice Samuel Alito and joined by four of the other conservatives, The Supreme Court in Dobbs v. Jackson Women’s Health Organization held that there is no federal constitutional right to an abortion, and that the decision to regulate abortion should be governed exclusively by state law. In doing so, the decision overruled The Supreme Court’s previous decisions of Roe v. Wade decided in 1973 and Planned Parenthood of Southeastern PA v. Casey decided in 1992.

The Dobbs opinion tracks closely with the previous leaked draft opinion from The Supreme Court and includes concurring opinions from Justice Thomas, Justice Kavanaugh, and Chief Justice Roberts, as well as a dissent by Justices Breyer, Sotomayor and Kagan.

The Chief Justice concurred in the judgment but wrote separately to indicate that he would have only upheld the Mississippi law, and stopped short of overturning the precedents of Roe and Casey.

Decision changes landscape of reproductive health care rights

The Court’s decision, which was effectively 6-3 given the Chief Justice’s concurrence in the judgment, changes the landscape of reproductive health care rights throughout the country.

Continue Reading Supreme Court Overturns Roe and Casey

Now that U.S. Supreme Court has overturned Roe v. Wade in Dobbs v. Jackson Women’s Health, the implications of that action will be far reaching both for fertility practices and for health care providers in general.

The Reed Smith Reproductive Health Working Group has generated a series of “unanswered questions” client updates to reflect the issues that a Roe reversal may have for these providers. An earlier post on this blog shared Part I of that series that focuses on the issues facing pharmacies.

In Part II of the series, Scot HasselmanLesley ReynoldsSarah Cummings Stewart, and John Kendzior analyze what the decision overturning Roe means generally for health care providers. Among the questions that are addressed are licensing issues, practice of medicine boundaries, oversight and compliance as well as issues for providers at long term care and other institutional settings.

In Part III of the series, Sarah Cummings StewartJohn KendziorArielle Lusardi, and Kristin Parker consider the implications of the reversal on providers whose practice includes fertility care. Specifically, the group discusses the applicability of so-called fetal “personhood” laws as well as conflicts of laws and religious objections. Additionally, there are questions that arise for embryo storage and transportation.

All of the client updates are available here:

Unanswered Questions Part I: Pharmacies

Unanswered Questions Part II: Health Care Providers

Unanswered Questions Part III: Fertility

Reed Smith will continue to monitor any state or federal responses to this decision. If you have any questions about this topic or how the Court’s opinion will affect your organization legally, please reach out to the health care lawyers at Reed Smith.

The Centers for Medicare & Medicaid Services (“CMS”) issued the first round of civil monetary penalties to two hospitals in Georgia for failure to comply with the requirements of the Hospital Price Transparency Final Rule (the “Rule”) on June 7, 2022.

According to the Notices of Imposition of a Civil Monetary Penalty published on the CMS Price Transparency Website, Northside Hospital Atlanta (“Northside Atlanta”) and Northside Hospital Cherokee (“Northside Cherokee”) failed to publish their standard charges and provide access to a machine-readable searchable tool, which would include standard prices for the hospitals’ items and services. CMS took this action after both hospitals failed to respond to the Warning Notices and Requests for Corrective Action Plans issued by CMS.

Effective January 1, 2021, hospitals must publish a machine-readable file that discloses the hospital’s negotiated rates with health plans, gross charges, discounted cash prices, and de-identified minimum and maximum negotiated charges for all items and services. Additionally, hospitals must publish a consumer-friendly, searchable tool that displays in plain language the prices of 300 shoppable medical services that a consumer can schedule in advance.

Continue Reading CMS levies penalties for non-compliance with Hospital Price Transparency Rule

As noted in an earlier post here, the U.S. Supreme Court is expected to issue an opinion in the Dobbs v. Jackson Women’s Health case sometime before its recess in July. A draft majority opinion, authored by Justice Samuel Alito and overturning Roe v. Wade, was leaked to news media in May.

While we won’t know the actual content or ruling of the decision until it is officially released, the leaked majority opinion gives a good indication that the precedent of Roe is either going to be overturned or severely limited. In anticipation of that occurring, Reed Smith has gathered a Reproductive Health Working Group consisting of attorneys and experts across the firm to provide analysis on the potential effects of the Dobbs decision.

As part of that effort, Scot HasselmanLesley ReynoldsSarah Cummings Stewart, and John Kendzior have put together the first of a number of client updates that should provide some clarity for what the expected overturn of Roe will mean for various health care entities. This first installment covers the unanswered questions for pharmacies should Roe be overturned.

The client update is available here.

Reed Smith will continue to monitor Supreme Court decisions as well as any state or federal responses to those decisions. If you have any questions about this topic or how the Court’s eventual opinion will affect your organization legally, please reach out to the health care lawyers at Reed Smith.

As the U.S. Supreme Court inches closer to the end of its term and a decision in a Mississippi abortion law case that is expected to either limit or eliminate the precedent of Roe v. Wade, the California Attorney General has urged mobile health app companies to safeguard the reproductive health data of people who use their apps.

Paul PittsSarah Bruno, and Smita Patil discuss the AG’s request and how the broad protections of California’s Confidentiality of Medical Information Act impact the health information gathering and security for mobile app companies in this Reed Smith client alert.

Reed Smith will continue to monitor Supreme Court decisions as well as any state or federal responses to those decisions. If you have any questions about this topic or how the Court’s eventual opinion will affect your organization legally, please reach out to the health care lawyers at Reed Smith.

On June 7, 2022, the Federal Trade Commission (FTC) announced that it would conduct an inquiry into the competitive impact of contracting and other business practices of pharmacy benefit managers (PBMs), including their effects on access to and affordability of prescription drugs.  As part of the inquiry, which is similar to FTC inquiries into other aspects of the health care industry, the FTC issued orders under Section 6(b) of the FTC Act requiring the six largest PBMs to provide information and records to the Commission. 

The five FTC commissioners voted unanimously on June 6, 2022 to conduct the study and issue the Section 6(b) orders.  According to the FTC mission statement, Section 6(b) “enables [the FTC] to conduct wide-ranging studies that do not have a specific law enforcement purpose.” 

In February, an earlier proposed review of PBMs failed to receive approval on a 2-2 party-line vote, with the two Republican Commissioners, Noah J. Phillips and Christine S. Wilson, voting against the proposed study. Commissioner Alvaro Bedoya was confirmed by the Senate in May, giving Democrats three seats on the Commission. 

Commissioners Phillips and Wilson issued a statement indicating that they had voted to approve the current inquiry because it has a different scope than the previously proposed study, including relationships between PBMs and both pharmacies and pharmaceutical manufacturers, “including, critically, how those practices might impact out-of-pocket costs for consumers.”

The FTC stated that its inquiry will examine PBMs’ role as middlemen who are hired by health plans to negotiate rebates and fees with drug manufacturers, create drug formularies and related policies, and reimburse pharmacies for patients’ prescriptions.  The Commission said that PBMs “often have enormous influence on which drugs are prescribed to patients, which pharmacies patients can use, and how much patients ultimately pay at the pharmacy counter.”  Chair Linda M. Khan stated that the FTC had received complaints about PBM practices from patients and professionals across the healthcare system, several of which the inquiry will examine.    

Continue Reading FTC announces inquiry into PBM practices and orders PBMs to provide information

The Centers for Medicare and Medicaid Services has published a final rule that governed the way that Medicare Advantage and Medicare Part D plans interact with third-party marketing organizations. The rule, which goes into effect on June 28, 2022, will have a wide ranging impact on the insurers who run these plans.

Scot Hasselman, Nicole Aiken-Shaban, and Whitney Petrie explore the implications of the rule for both plans and third party marketing organizations in this Reed Smith client alert.

Reed Smith will continue to follow developments in the regulation of Medicare Advantage and Part D plans if you have any questions about this or any other CMS regulations please reach out to the health care lawyers at Reed Smith.

Last month’s leaked U.S. Supreme Court draft majority opinion from Justice Alito in Dobbs v. Jackson Women’s Health Organization that would overturn Roe v. Wade and Planned Parenthood v. Casey could have long reaching effects for health law beyond the obvious liability for providers who are involved in women’s health and abortion. If the opinion does reflect the judgment of a majority of the Court, then it could impact even drug and device companies in ways that were not obvious from the face of the opinion.

Reed Smith has established a working group to evaluate the impact of the decision on our health care and life sciences clients.  The group includes our products liability colleagues who author the Drug and Device Law Blog and have written a post about how the Court’s supposed action would affect medical product manufacturers.

That post is available on the Drug and Device Law Blog here.

Reed Smith will continue following developments as the Supreme Court term comes to a close this month. If you have any questions about what impact this pending decision may have on your practice or business or what the Court’s opinion will mean for you when it does eventually come out, please contact the health care lawyers at Reed Smith.

Supreme Court review of Rule 9(b)’s application in False Claims Act cases may finally be coming whether the Executive Branch likes it or not.

In January, the Supreme Court, which is considering a certiorari petition in Johnson v. Bethany Hospice and Palliative Care, LLC, asked the Solicitor General to weigh in on whether the Court should accept the case. The case presents the question of what Rule 9(b) requires in cases arising under the False Claims Act, which is an important threshold question in many False Claims Act cases resulting in significant motions practice.

As past Solicitors General have done before her, the current Solicitor General’s brief filed late on May 24 argued that the Supreme Court should not grant plenary review because there really isn’t a meaningful circuit split on the issue. The brief also argues that the case is not a good vehicle for Supreme Court review because the district court dismissed the relator’s case on the alternative ground that the relator had not adequately pleaded violations of the federal anti-kickback statute, an issue the U.S. Court of Appeals for the Eleventh Circuit did not reach on appeal.

Continue Reading SCOTUS Review of Rule 9(b) in False Claims Act cases may be on the way

On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA’s review as part of original new drug applications (NDAs), original biologics license applications (BLAs), or supplements to such applications.

In the draft guidance, FDA reiterates its risk-based regulatory approach and applies it in the product quality assessment context.  Specifically, the draft guidance states that FDA continues to identify potential risks to product quality associated with the formulation, manufacturing process, and packaging components when conducting a product quality assessment as well as the proposed control strategy for mitigating those risks.

Continue Reading FDA issues draft guidance for use in product quality assessments

CMS recently issued updated Open Payments Frequently Asked Questions (FAQs). The FAQs are revised periodically to reflect the most up to date program requirements. This latest revision both added and removed FAQs, and also included some general edits.

The following FAQs were added: #2014, #2015, #2016, #2017, #2018, #2019, #2020, #2021 and #2022. Each new FAQ is reproduced in full below. They provide additional guidance regarding topics such as archived reporting years, salaries paid to covered recipients, reporting of device identifiers, valuing long-term device loans, debt forgiveness, and the definition of Nurse Practitioner.

Additionally, the following FAQs have been removed from the FAQ document “due to being no longer applicable, redundant with another FAQ, or of low utility” (according to CMS): Continue Reading CMS Issues Updated Open Payments FAQs

On April 8, 2022, President Biden issued a memorandum ordering his executive departments to take steps to combat the long term effects of COVID-19.

In particular, the memorandum focused on efforts to address the effects of “Long COVID.” The memorandum noted that “Long COVID” symptoms “can include anxiety and depression, fatigue, shortness of breath, difficulty concentrating, heart palpitations, disordered sleep, chest and joint pain, headaches, and other symptoms.” Further, the memorandum also acknowledged that “Long COVID” can affect a wide-range of people regardless of race, ethnicity, underlying conditions, or even severity of original infection.

The memorandum requires the Secretary of Health and Human Services to work with the heads of agencies as well private experts, organizations, and stakeholders to coordinate a government-wide response to “Long COVID.” Further, the Secretary must publish a public report within 120 days regarding government support services available or that will be available to those experiencing “Long COVID,” those experiencing loss because of COVID-19, and those who are experiencing mental health and substance use issues due to the pandemic. The report must also directly address disparities in these services available to underserved communities. Continue Reading Biden administration announces efforts to combat “Long COVID”

In a notice published on April 7, 2022, the Health Resources and Services Administration (HRSA), the division of HHS that manages the distribution and oversight of CARES Act Provider Relief Funds (PRFs), requested comments from stakeholders on proposed changes to its Information Collection Request (ICR) Form that it will be submitting to the Office of Management and Budget (OMB).

The approved ICR uses an OMB form that is set to expire on January 1, 2023, so HRSA is requesting comments before submitting revisions to OMB. This is the first opportunity for providers who were subject to the first two PRF reporting periods (Period 1 and Period 2) to comment on the reporting program and provide feedback on requirements related to those reports. In addition to revising the PRF reporting form, HRSA is looking to add reporting for the American Rescue Plan (ARP) rural provider program to the ICR.

The ARP rural provider program was put in place by Congress to provide payments to providers and suppliers who served rural Medicaid, CHIP and Medicare beneficiaries from January 1, 2019 through September 30, 2020. The ARP Rural plan is distinct from the PRF, but it has similar reporting requirements and uses the PRF reporting portal for applications. Continue Reading HRSA asks for comment on provider relief fund and ARP rural reporting requirements

The Department of Health and Human Services (HHS), through its Health Resources and Services Administration (HRSA) office, is taking action to recoup CARES Act funding from health care providers who received relief funding but did not meet the reporting requirements set by HRSA.

To receive COVID-19 relief funding from HRSA pursuant to the CARES Act, providers had to attest to compliance with the terms and conditions promulgated by HRSA. Recipients of the funds must agree to the terms and conditions specific to the Phase in which they received funding distribution. Those terms and conditions evolved over time, with different reporting periods for each wave of funding. Under all waves, failure to report to HRSA regarding the use or allocation of received funds constitutes noncompliance with HRSA’s terms and conditions and requires repayment of the funds.

Providers who completed reporting, but reported unused funds, will have 30 days from the end of their specific reporting deadline to return all unused funds. Continue Reading Provider relief fund reporting: HRSA to recoup funds from providers who didn’t meet deadlines

The Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued a favorable advisory opinion to a digital health company that offers direct monetary incentives to patients as part of a technology-enabled contingency management program for patients with substance use disorders.

Contingency management, also known as motivational incentives, is a treatment approach that utilizes tangible rewards to reinforce positive behaviors (e.g., abstinence from opioids) and to motivate and sustain behavioral health efforts (e.g., treatment adherence) in patients who suffer from substance use disorders. Because these monetary incentives are an integral part of the protocol-driven and evidenced-based program, the OIG concluded that it would not impose sanctions under the federal Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Monetary Penalty (“CMP”) provision, notwithstanding the involvement of federal health care program beneficiaries, providers/suppliers, and reimbursable services.

Nevertheless, the mitigating facts that motivated the OIG’s favorable treatment of the program here—namely, the clinical nature and independence of the program—could likely trigger compliance with other federal and state regulatory frameworks. Continue Reading OIG blesses digital health substance use disorder treatment program paid for by providers and suppliers

The Occupational Safety and Health Administration (“OSHA”) has reopened the comment period on its June 2021 interim final rule establishing an Emergency Temporary Standard governing occupational exposure to COVID-19 in healthcare settings, codified at 29 C.F.R. § 1910 Subpart U (“Healthcare ETS”).

While this reopening reaches certain questions and issues presented by OSHA and not the entire rule, the reopening of the comment period signals the beginning of the effort to finalize a permanent standard by OSHA only three months after the agency withdrew the Healthcare ETS. The Healthcare ETS required healthcare organizations to develop a COVID-19 plan for its workplace that included health screening and management, masking, distancing, and support for vaccination. The Healthcare ETS was withdrawn in December 2021 because OSHA determined that its efforts to establish a permanent standard would exceed the six-month time period allowed under the Occupational Safety and Health Act.

The notice reopening the comment period gives stakeholders both an early view into potential regulatory outcomes of the final rule as well as a series of information requests. Continue Reading OSHA reopens comments on COVID-19 Healthcare Emergency Temporary Standard

In a March 11 advisory opinion the Department of Health and Human Services’ Office of Inspector General (“OIG”) permitted a medical device manufacturer to pay Medicare-reimbursable costs for subjects enrolled in a clinical trial sponsored by the manufacturer and involving the manufacturer’s therapy.

The OIG indicated it would not impose administrative sanctions, despite the fact that the proposed arrangement would generate remuneration prohibited under the federal Anti-Kickback Statute (“AKS”) and the beneficiary inducement prohibition (“Beneficiary Inducement CMP”).

Arrangement addresses socioeconomic barriers for potential participants while maintaining study integrity

The therapy, which involves the injection of the subject’s bone marrow cells into the subject’s heart as a potential treatment for heart failure, is currently available for clinical use in the United States pursuant to an FDA-approved Category B Investigational Device Exemption (“IDE”).

Studies involving an IDE device qualify for Medicare coverage of the device and routine care services and items so long as the study is specifically approved by the Centers for Medicare and Medicaid Services (“CMS”). The study at issue here was approved for Medicare coverage and was required to meet a number of criteria for approval, including a determination that:

  • The principal purpose of the study is to test whether the device improves health outcomes of appropriately selected patients;
  • The rationale for the study is well supported by available scientific and medical information, or it is intended to clarify or establish the health outcomes of interventions already in common clinical use; and
  • The study results are not anticipated to unjustifiably duplicate existing knowledge.

Under the proposed arrangement, the manufacturer would directly pay an institution for the costs of the Medicare-reimbursable device and costs of routine care services and items that Medicare beneficiaries participating in the Study would otherwise owe. These costs per Medicare beneficiary (estimated as upwards of $1,300) were considered to be cost-prohibitive for many subjects due to their socioeconomic situations. As such, the proposed arrangement would ensure that Medicare beneficiaries participating in the study would incur no additional out-of-pocket expenses other than any unmet deductibles under Medicare Part B.

Additionally, the manufacturer represented that information regarding this proposed arrangement would not be shared with subjects until they received informed consent documents. This would preserve the study’s blinding procedures and ensure that subjects were unaware whether they were part of the study’s control group. This last aspect was a result of the manufacturer’s desire not to have providers collect cost-sharing amounts from control-group beneficiaries because the control group subjects do not have the potential to receive any therapeutic benefit during the study.

Arrangement qualifies as remuneration under AKS and Beneficiary Inducement CMP

OIG noted that the proposed arrangement involved remuneration that would directly implicate the federal AKS and the Beneficiary Inducement CMP.

AKS defines remuneration as “the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind”. Similarly, the Beneficiary Inducements CMP defines remuneration as “the transfer of items or services for free or for other than fair market value”. However, the Beneficiary Inducements CMP contains an exception to the term “remuneration” for waivers of coinsurance and deductible amounts by a person if: (i) the waiver is not offered as part of any advertisement or solicitation; (ii) the person does not routinely waive coinsurance or deductible amounts; and (iii) the person waives the coinsurance and deductible amounts after determining in good faith that the individual is in financial need or fails to collect coinsurance or deductible amounts after making reasonable collection efforts.

Here, OIG determined that the proposed arrangement implicated AKS as the remuneration offered could induce Medicare beneficiaries to participate in the study to receive reimbursable benefits, and such benefits could be from a particular practitioner, provider, or supplier. Additionally, the Beneficiary Inducements CMP was implicated because the proposed arrangement involved the opportunity for investigators and sites to bill Medicare for items and services related to the study and offered a guaranteed payment of beneficiary cost sharing, which, in some circumstances, an investigator or site may not be able to collect in full.

OIG determined proposed arrangement was reasonable and of minimal risk of fraud and abuse

OIG’s analysis determined that the proposed arrangement would present a sufficiently low risk of fraud and abuse and be unlikely to lead to overutilization of services and increased federal health care program costs for the following reasons:

  • The proposed arrangement appeared to be a reasonable means of promoting enrollment, particularly where a portion of participating beneficiaries would not have the potential to receive any therapeutic benefit during the study. The cost-sharing subsidies offered would help facilitate sufficient enrollment in the study that would otherwise be hindered due to a participant’s financial constraints. The cost-sharing subsidies would also encourage completion of the entire course of the study as required follow-up clinical visits would, absent the subsidy, require beneficiaries to pay. By removing this financial barrier, the study could achieve accurate results and reduced the likelihood that beneficiaries would not complete the study in its entirety.
  • The proposed arrangement would pose a low risk of overutilization or inappropriate utilization of items and services payable by Medicare. The proposed arrangement included various guardrails that mitigate the risk of inappropriate utilization or improper increased costs, and the manufacturer certified it would not advertise the availability of cost-sharing subsidies. Such guardrails included the fact that beneficiaries had to satisfy enrollment criteria set forth in the study and execute an informed consent agreement, investigators had to follow study protocol and were subject to IRB monitoring and the study’s enrollment being capped at 260 subjects. Moreover, CMS approval of the study meant that the study met criteria to ensure appropriate patient protections and that the study design was appropriate to answer questions of importance to the Medicare program and its beneficiaries.
  • The proposed arrangement was distinguishable from problematic seeding arrangements, such as those in which manufacturers initially offer subsidies to lock in future utilization of a reimbursable item or service. While beneficiaries participating in the study may continue to receive follow-up services related to the therapy, the manufacturer is in no position to benefit financially from these follow-up services. The manufacturer indicated that the therapy is intended to be a one-time treatment and that it did not anticipate future utilization of the therapy or its other products by Study participants.

Health Industry Washington Watch previously covered an advisory opinion issued by OIG on February 4, 2022 involving approval of a similar arrangement involving a testamentary gift to a nonprofit hospital to reduce costs for pediatric patients. Although OIG has permitted this proposed arrangement, there is no guarantee that similarly structured subsidizations of costs would be immune from administrative sanction. Nevertheless, the analysis of the arrangement outlined in this latest advisory opinion sheds some light on how similar future arrangements are likely to be reviewed and analyzed by the OIG.

Should you have any questions related to this advisory opinion, or any other health care compliance issues, please do not hesitate to reach out to the health care attorneys at Reed Smith.

On March 18, 2022, the Advanced Medical Technology Association (AdvaMed) – the world’s largest trade organization representing medical technology manufacturers – announced revisions to its Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code). The effective date of the revised AdvaMed Code is June 1, 2022.

The AdvaMed Code was updated to address arrangements to advance value-based care, consistent with the recent Anti-Kickback Statute (AKS) value-based safe harbor rules, as well as the U.S. Department of Health & Human Services, Office of Inspector General’s (OIG) November 2020 Special Fraud Alert on Speaker Programs. AdvaMed issued a revised Code, FAQs, and a standalone guidance document.

Key updates in the AdvaMed Code include guidance with respect to:

  • Providing alcohol at Company-conducted programs and meetings;
  • Virtual meetings and programs;
  • Interactions and arrangements with HCPs relating to value-based care (e.g., results-based, outcomes-based, or performance-based arrangements); and
  • Leveraging data and technology to provide innovative solutions and cost-effective care.

AdvaMed’s newest guidance follows shortly behind an August 2021 announcement by the Pharmaceutical Research and Manufacturers of America (PhRMA) – which represents the nation’s leading biopharmaceutical research companies – that it updated its Code on Interactions with Health Care Professionals, to address many of the same topics. The updated PhRMA Code took effect January 1, 2022.

Medical technology companies would be well-served to review the revised AdvaMed Code and guidance and consider adjustments to their current compliance operations in light of the updates.

Reed Smith is honored to serve as outside counsel to AdvaMed and we are pleased and available to provide additional information on and assistance with implementing the revised AdvaMed Code. Please reach out to the authors of this post or the Reed Smith attorneys with whom you regularly work for more information or guidance on these changes.

The House Energy and Commerce Committee seems poised to make substantial changes to the Food and Drug Administration’s (“FDA’s”) Accelerated Approval Program. The committee’s Democratic chairman, Frank Pallone, Jr. (D-NJ) and Republican ranking member, Cathy McMorris Rodgers (R-WA) have proposed competing bills that were featured prominently in the Health Subcommittee’s legislative hearing on March 17, 2022.

The Accelerated Approval Program was developed in 1982, largely in response to the HIV/AIDs epidemic, to expedite approval of novel drugs that treat serious conditions with unmet medical needs based on a surrogate endpoint.  Drugs that receive accelerated approval must undergo post-approval (Phase IV) studies to confirm the intended clinical benefit.  If the clinical testing does not demonstrate the intended clinical benefit, FDA has mechanisms to remove the drug from the market.

However, concerns have mounted regarding FDA’s ability to remove ineffective drugs from the market, and those concerns were punctuated during a February 3, 2022 Health Subcommittee hearing on the reauthorization of FDA User Fees. Dr. Patrizia Cavazzoni, the Director of the Center for Drug Evaluation and Research at the FDA testified that the program’s existing mechanism to withdraw accelerated approvals is cumbersome, resource intensive, and seldom used.

Continue Reading Competing bills propose amendments to FDA’s accelerated approval program