Jay Jackson conducts evidence-based assessments of the regulatory and policy environments for approval of and market access for medical products.

Prior to joining Avalere, Jay performed research and analysis on legislative and public health issues in the Colorado Senate. Prior to that, he conducted human genomic research at the University of Colorado. Jay currently focuses on conducting healthcare clinical and economic research, analysis of legislation, federal policy and regulations, and engagement with healthcare payers and providers. Jay’s areas of expertise include market access, reimbursement, and FDA regulation, with special expertise in devices, diagnostics, and value-based evidence communication.

Jay holds an MPH in health systems management and policy from the University of Colorado School of Public Health, a BS in microbiology and cell science from the University of Florida, and a regulatory affairs certification.

Authored Content

Avalere experts hosted a lively discussion on the 2019 outlook for the medical device industry.

While precision medicine is expected to revolutionize patient therapy, the increasing complexity of diagnostics is leading policymakers to revamp the way these tests are regulated and paid for.

In its proposed changes to the Medicare Physician Fee Schedule (MPFS) for Calendar Year 2019 (CY2019), the Centers for Medicare & Medicaid Services (CMS) proposes a potentially sweeping change to the way it values physician office and outpatient visits, also known as Evaluation & Management (E/M) codes.

Avalere evaluated payer policies for biologics when biosimilars are available.

Most people are familiar with generic drugs as less costly alternatives to drugs whose patents have expired.

The FDA Reauthorization Act of 2017 (FDARA), which was signed into law on August 18, 2017, calls on FDA to examine underlying barriers to access to investigational drugs.

Today, the Senate voted to pass H.R.2430, the FDA Reauthorization Act of 2017.

New research from Avalere finds that most health plans are covering at least one of the two biosimilar products currently on the market.

The 21st Century Cures Act presents medical product manufacturers, patient groups, and advocacy organizations with a unique opportunity to plan for upcoming policy changes that are aimed at accelerating the pace of development and approval of new therapies.

The 21st Century Cures Act requirement to post compassionate use policies may explain increase.

The final signing of the 21st Century Cures Act is the culmination of 3 years of efforts by lawmakers in the House and Senate to expedite developing and making available new treatment options. In the final episode in our series, Jay Jackson discusses what changes are on the horizon for products under The Cures Act.

The final signing of the 21st Century Cures Act is the culmination of three years of efforts by lawmakers in the House and Senate to expedite developing and making available new treatment options. Listen to Cara Kelly break down the impacts in episode 1 of our series on 21st Cures.

Today, the House will vote on the updated version of the 21st Century Cures Act, H.R. 34.

Proposed Requirements in 21st Century Cures Act Would Increase Transparency Requirements

Since 1992, the Food and Drug Administration (FDA) has collected $7.67 billion in user fees from pharmaceutical manufacturers to fund drug reviews based on an Avalere analysis of FDA data.

The US Food and Drug Administration (FDA) makes its medical product marketing approval decisions based on a risk–benefit determination of safety and effectiveness.

Listen as our expert, Jay Jackson, discusses recent final guidance issued by the FDA on compassionate use.

With the recent announcement of the U.S. Food and Drug Administration's (FDA) acceptance of a submission for approval of a second biosimilar to Remicade (infliximab), questions remain for biologics manufacturers, payers, prescribers, and others as to how a mature biosimilars pipeline will begin to evolve in the United States and whether a sustainable competitive specialty market will develop.

Two Potential Policy Changes Would Reduce Out-of-Pocket Costs for Consumers

In Biosimilars, Avalere's Gillian Woollett shares commentary on future considerations for the role of clinical trials in the development of biosimilars.

The U.S. Food and Drug Administration's (FDA) Advisory Committee (AdComm) process remains a source of significant uncertainty for medical product manufacturers, despite FDA's guidelines in the Code of Federal Regulations (C.F.R.)1 and in guidance.2 While the AdComm process is generally the same across Centers,3 each AdComm is unique and subject to the expertise and opinions of individual panel members, opinions voiced during the public comment period, and challenges exclusive to each new product or indication.

New research from Avalere Health finds that 86% of pharmaceutical companies would invest more in studies to support the development of healthcare economic information if provided additional guidance on their ability to use this evidence with external audiences.

Even during these gridlocked times in Congress, certain healthcare initiatives are getting through the cracks; one of these such initiatives is 21st Century Cures.

On Aug. 11, Celltrion announced the completion of their 351(k) filing procedure to FDA on Aug. 8, for its Remicade (infliximab) biosimilar product, Remsima (infliximab).

Avalere impressions on the first FDA biosimilar filing.

On May 13, FDA released a draft guidance describing the clinical pharmacology data needed to support a demonstration of biosimilarity to a reference product.