The FDA has announced a notice of a comment period extension. The FDA originally solicited the industry in an April 3, 2019 notice, seeking comments to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
If you are interested in submitting comments to the docket or need assistance navigating the unsettled and complex regulatory environment for cannabis-derived products including CBD, Frier Levitt Government Affairs and Frier Levitt, LLC can help. Contact us today.
On May 31, 2019, the Food and Drug Administration (FDA) held a widely anticipated public hearing to gather information on the use of cannabis and cannabis-derived compounds, including cannabidiol (CBD), in consumer products such as foods, dietary supplements and cosmetics. Although FDA did not reveal any new regulatory pronouncements, the hearing marks an important initial step in the Agency’s on-going evaluation of a potential evidence-based regulatory pathway for such products.
At the hearing, Acting Commissioner Dr. Ned Sharpless delivered opening remarks and reiterated that recent changes to federal and state law, and the explosion of CBD products in the marketplace, have not affected FDA’s view that CBD cannot be lawfully added to any FDA-regulated consumer product. While the Agriculture Improvement Act of 2018 (the “Farm Bill”) generally legalized CBD derived from hemp (defined as cannabis with THC content below 0.3% by dry weight), the Farm Bill explicitly preserved FDA’s authority to regulate foods, drugs, dietary supplements and cosmetics containing CBD. Dr. Sharpless said critical questions remain about the safety of widespread CBD use and the Agency will carefully evaluate whether evidence supports the broad use of CBD in FDA-regulated products.
Echoing his predecessor Dr. Scott Gottlieb, Dr. Sharpless noted that FDA is primarily concerned with over-the-counter CBD products that claim to prevent, diagnose, mitigate, treat or cure serious diseases such as cancer. While FDA enforcement to date has focused on CBD products making egregious disease claims, Dr. Sharpless noted that FDA does not have a policy of enforcement discretion with respect to any CBD products.
Over 100 people testified at the hearing from a broad range of interest groups including academia, health professionals, agriculture, manufacturers, retailers, distributors, consumer groups, patients, state governments, public safety organizations, and legal professionals. Speakers discussed a wide array of uses for CBD products and provided anecdotal and scientific conclusions regarding CBD use. Several speakers described the current CBD market as the ‘Wild West’ and emphasized the need for instituting quality assurance and good manufacturing standards. Many speakers also addressed the difficulty of testing CBD products in the current legal environment and how that hinders the creation of quality CBD products.
Comments to the FDA docket may be submitted until July 2, 2019.
If you need assistance navigating the unsettled and complex regulatory environment for cannabis-derived products including CBD, or if you are interested in submitting comments to the docket, contact Frier Levitt Government Affairs today.
With the 2020 political season quickly approaching, healthcare and life sciences industry stakeholders have started showing interest in forming Political Action Committees (PACs).
A Political Action Committee or (PAC) is organized for the purpose of raising and spending money to either help candidates elected or defeated. These organizations represent industrial or ideological interests and are regulated under either state or federal campaign finance laws depending on the PAC’s usage.
PACs continue to be influential under the right guidance. Stakeholders that are more aggressive in advancing their political agendas have found that the use of PACs are effective in getting their respective messages out. Frier Levitt Government Affairs helps organizations create PACs and provides ongoing consultation regarding compliance, policy recommendations, and other strategic suggestions to help organizations achieve their respective goals.
The Massachusetts Health Policy Commission has released its analysis of state PBM activity titled, Cracking Open the Black Box of Pharmacy Benefit Managers. Notably, the report concludes the need for additional PBM oversight and scrutinized the practice of PBM spread pricing.
According to the report, PBM spread pricing practices appear to be increasing in Massachusetts: “…this practice covered 22% of PBM compensation in 2014, but rose to 54% in 2016. This practice, often used as a means of payment for PBM services instead of administrative fees, may have significant impacts on public insurance programs, employer health plans, and consumers. Additionally, the media has reported growing concerns from pharmacists about low reimbursement rates from PBMs in Massachusetts and other states. PBM payments to pharmacies are sometimes even below the pharmacy’s acquisition costs of the drugs, which can affect the financial viability of pharmacies and potentially impact access to care. Yet the extent to which PBMs profit from this practice, and on which drugs, remains largely hidden from payers and the public.”
Additionally, the Commission cited, “As part of the fiscal year 2020 state budget strategy on MassHealth drug prices, the Baker-Polito administration proposed a new requirement for PBMs to be transparent about their pricing and to limit PBM margins under contracts with MCOs and accountable care organizations (ACOs), which the administration projects will save $10 million. To advance transparency, MassHealth recently released a bulletin directing MCOs and MassHealth Accountable Care Partnership Plans to obtain and submit to MassHealth drug-specific data from their PBMs including payments to dispensing pharmacies and rebate and administrative payment data.”
Based on recent activities and discussions with Massachusetts, additional PBM policies are forthcoming. Frier Levitt Government Affairs’ (FLGA) forecasting and monitoring services help keep healthcare and life sciences stakeholders “in the know” regarding pending policy and marketplace changes. Forecasting and monitoring helps stakeholders make better strategic decisions so that they no longer just “reacting” to outside changes. Contact FLGA today for forecasting and monitoring services tailored for you and your organization.
Frier Levitt Government Affairs (FLGA) works with different individuals within the healthcare and life sciences sectors to provide relevant and up-to-date content for your immediate needs. This includes producing industry-leading white papers to circulate among the industry and content creation for websites, newsletters, and publications. FLGA also creates content specific to your organization for “leave behind” packets to help policymakers understand your issues. FLGA has extensive experience in tailoring content to specific audiences to help showcase products, services, or industry.
Types of content include, but are not limited to:
• White papers for state or national organizations
• Informative content regarding recent state or national policy trends to send to your membership
• “Leave behind” packets detailing your issues for meetings with legislators
Contact FLGA today to learn content options to meet your needs.
New York State Senator James Skoufis, Chair of the Senate Committee on Investigations & Government Operations, in coordination with Senator Gustavo Rivera, Chair of the Senate Committee on Health, has released the Final Investigative Report: Pharmacy Benefit Managers in New York. The report comes after the Committee opened an investigation into the practices of Pharmacy Benefit Managers (PBMs) in New York State in January 2019.
Some key findings of the report include:
• One of the key mechanisms by which PBMs generate revenue is through spread pricing
• The lack of transparency and oversight of PBMs has created an environment in which PBMs are able to engage in self-dealing to the detriment of consumers across New York State
• New York State must take immediate action to regulate the practices of spread pricing, MAC appeals, mail order operations, and reimbursements
• The New York State Comptroller should perform a full audit of all dollars paid to PBMs via spread pricing
Legislative recommendations provided by the report include:
• Regulate the practices of spread pricing in all pharmacy benefit contracts
• Enhance the transparency of MAC appeals
• Require the licensing and registration of PBMs to enhance accountability and oversight by instituting a fiduciary duty for their clients
• Prohibit PBMs from mandating that patients use specialty and mail order pharmacies
• Providing for the adequate and transparent reimbursements for pharmacies
• Require PBMs to pass-through all discounts or rebates received from drug manufacturers to its Medicaid managed care clients
This is definitely not the last time New York, or any other state, will develop policies to help regulate abusive PBM practices. Frier Levitt Government Affairs (FLGA) is constantly monitoring new state PBM policies and working with pharmacy stakeholders nationwide to have their voices heard. Contact FLGA today to learn more about getting involved.
Over the last week, three states- Alabama, Illinois and Louisiana- sent legislation to their respective Governor’s to sign aimed at fighting back against Pharmacy Benefit Managers (PBMs). Highlights of the pending legislative bills include:
Effective January 1, 2020, a PBM must be licensed by the Commissioner. The legislation also prohibits gag clauses. Furthermore, a health plan may not include a provision that requires an enrollee to make a payment for a prescription drug at the point of sale in an amount that exceeds the lessor of:
1. the contracted co-payment amount; or
2. the amount an individual would pay for a prescription if that individual were paying with cash.
This bill states that a contract between a health insurer and PBM must:
1. Require the PBM to update maximum allowable cost pricing information and maintain a process that will eliminate drugs from maximum allowable cost lists or modify drug prices to remain consistent with changes in pricing data
2. Prohibit the PBM from limiting a pharmacist’s ability to disclose the availability of a more affordable alternative drug
3. Prohibit the PBM from requiring an insured to make a payment for a prescription drug in an amount that exceeds the lesser of the applicable cost-sharing amount or the retail price of the drug
• Prohibits PBM spread pricing unless the PBM provides written notice consisting of spread pricing transparency to the insurer
• Provides the Board of Pharmacy with PBM oversight
• Requires PBM licensure
• Strengthens maximum allowable costs (MAC) requirements
• Creates a PBM monitoring advisory council
• Prohibits unfair or deceptive trade practices by PBMs including prohibits them from patient steering to a PBM owned pharmacy without disclosure and prohibits penalizing beneficiaries or inducing them to use a pharmacy that is PBM owned
• Prohibits retroactive denials or reductions in pharmacy claims that have already been approved by the PBM
This legislation provides a model for other states on ways to combat abusive PBM tactics.
Frier Levitt Government Affairs (FLGA) monitors new legislative developments for pharmacy stakeholders and provides tools to help keep them “in the know.” Contact FLGA today to learn more about new legislative developments and for help preparing legislation that will get you back on track to attaining a level playing field for your respective state(s).
