Tag: FDA

FDA Announces it is Expediting Review of CBD

On July 12, 2019, Food and Drug Administration (FDA) Principal Deputy Commissioner Dr. Amy Abernathy announced via Twitter that the FDA is expediting its work to address the regulation of cannabidiol (CBD). She stated that FDA intends to report on its progress “around end of summer/early fall.”

Dr. Abernathy added that the FDA is enthusiastic about research into the therapeutic benefits of CBD products but reiterated the need to balance safety concerns. She also acknowledged the intense interest around this issue by saying that in addition to the over 100 speakers who presented at the May 31 FDA public hearing on cannabis products, there have been 3,417 comments submitted to the public docket (with four days remaining before the July 16 deadline).

Congress has also recently pressed the FDA for expedited action on CBD regulation. Senator Ron Wyden, D-Ore., sent the FDA a letter on June 25 urging the FDA to promptly issue guidance that ensures a regulatory pathway for the lawful use of hemp-derived CBD as a food additive and as an ingredient in dietary supplements. He called for FDA to issue an “enforcement discretion guidance” by August 1.

On the other side of the aisle, Senator Mitch McConnell, R-KY, met with Acting FDA Commissioner Dr. Ned Sharpless on June 28 and urged him to develop regulations to allow hemp-derived CBD to be lawfully marketed.

The House also recently passed an amendment to appropriations legislation directing FDA to “undertake a process to make lawful a safe level for conventional foods and dietary supplements containing [CBD] so long as the products are compliant with all other FDA rules and regulations.”

The emerging CBD industry creates opportunities for current participants in the drug supply chain, physicians, and other healthcare providers. However, anyone either currently involved in marketing or providing CBD products or those desiring to get into the CBD market should engage qualified guidance. Frier Levitt Government Affairs and Frier Levitt are committed to the healthcare industry and can provide sage advice to providers. Contact us today.

FDA Extends Comment Period on Products Containing Cannabis

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.

In addition to establishing a docket for public comment from its May 31, 2019 public hearing on the issue, the FDA has now extended its comment period until July 16, 2019.

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.

FDA Conducts Anticipated Hearing on the Regulation of CBD Products

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.

Service Spotlight: Engaging in Regulatory Comments to Protect Company Operations & Margins

Proposed regulations are something that are underutilized by healthcare and life sciences supply chain entities. While legislation captures all the excitement with lobbying and either amending or passing new laws, when it comes to healthcare, the gaps legislation oftentimes leaves open-ended are left to an agency to do the details of filling in the gaps. For example, specifics on reimbursement or licensing changes are usually done by the likes of CMS, FDA, HRSA or state departments of insurance.

Changes are done via rulemaking, which are found in the federal or state register. Through proposed rules, agencies give stakeholders an opportunity to comment on a rule change, which starts a certain timed process.

Participation in agency rulemakings are key because these rules affect the finer points of your operation. Additionally, not knowing about a change in these critical rules can oftentimes result in adverse action from an agency like a fine or a warning letter if your compliance is not up to date.

Frier Levitt Government Affairs (FLGA) guides healthcare and life sciences stakeholders through the regulatory comment process. FLGA looks at your business model, monitors for proposals that will impact you, and counsels you on strategic next steps. Additionally, healthcare and life sciences stakeholders will get the benefit of working with boutique healthcare law firm Frier Levitt, LLC, who will help ensure that your company stays compliant with any news rules that are promulgated.

FLGA offers a hybrid service flexible with an organization’s changing needs. We monitor and forecast regulatory issues of importance in a concise, easy to understand and time friendly format. Our monitoring and forecasting services allow stakeholders to stay educated and engaged on new developments before the trends become mainstream.

With regulations changing all the time, it is imperative for healthcare and life sciences stakeholders and organizations to be proactive instead of reactive. Contact Frier Levitt Government Affairs today to get “in the know” and finally be prepared for regulatory changes ahead.

Service Spotlight: Monitoring & Forecasting Keeps Healthcare and Life Sciences Stakeholders “In the Know”

Many healthcare and life sciences industry stakeholders often wish they knew about pending laws before they are enacted, why a new regulation was drafted the way it was, or why they are being asked about information from a supply chain partner on an issue they knew nothing about. Not being “in the know” raises the risk of being unprepared for an emerging law or regulation and can also hurt a business’ bottom line.

Frier Levitt Government Affairs (FLGA) offers a hybrid service flexible with an organization’s changing needs. FLGA monitors and forecasts issues of importance for healthcare and life sciences stakeholders, including state and federal legislation and regulation, all presented in a concise, easy to understand and time friendly format. FLGA’s monitoring and forecasting services allow stakeholders to stay educated and engaged on new developments before the trends become mainstream.

With laws and regulations changing all the time, it is imperative for healthcare and life sciences stakeholders and organizations to be proactive instead of reactive. Contact Frier Levitt Government Affairs today to get “in the know” and finally be prepared for the changes ahead.

Demystifying CBD: What You Need to Know About the Growing Cannabidiol Market

Cannabidiol (CBD) products have seemingly flood the market, suddenly springing up in many places. This has lead pharmacies, natural health food stores and other retailers to discuss new strategies to position themselves in the developing market of CBD. However, recent market saturation and uncertain regulatory oversight have caused massive confusion of whether these products are legal or not.

In this recorded webinar, Ron W. Lanton, Esq., Executive Director of Frier Levitt Government Affairs, explores several issues around CBD, including:
• CBD vs. THC
• An examination of current state and federal CBD and Marijuana policies
• A discussion of current administration viewpoints, including the FDA and DEA
• Other related business trends

Viewers of this webinar will be able to:
• Understand relevant CBD terms
• Comprehend the current viewpoints CBD and Marijuana policies and business trends
• Pinpoint the relationship of the FDA and DEA on CBD

Contact Frier Levitt Government Affairs today.

FDA Seeking Comments on New Guidance Regarding Rare Diseases

The FDA has released a new draft guidance document titled, “Rare Diseases: Natural History Studies for Drug Development.” The guidance document impacts pharmacy supply chain stakeholders, especially drug manufacturers and specialty interests.

What Does the Guidance Do?

According to the FDA, the Agency is publishing this draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of safe and effective drugs and biological products for rare diseases. A natural history study collects information about the natural history of a disease in the absence of an intervention, from the disease’s onset until either its resolution or the individual’s death. Although knowledge of a disease’s natural history can benefit drug development for many disorders and conditions, natural history information is usually not available or is incomplete for most rare diseases, therefore, natural history information is particularly needed for these diseases.

Why You Should Participate:

If you are supply chain stakeholder looking to diversify your business into biological products or to serve rare disease patients, the trend is pointing towards greater utilization of specialty products. Comments are suggested to ensure that the government has your viewpoint in mind when developing further guidance and proposed rules.

There are multiple ways to respond to the “Rare Diseases: Natural History Studies for Drug Development” guidance document. Contact Frier Levitt Government Affairs to have your voice heard.

What You Need to Know about Biosimilars with Brian Lehman, Director, Medical Account Management and Strategic Alliances for Sandoz Inc.

In the first of a series of interviews for the Frier Levitt Government Affairs blog, Executive Director Ron Lanton, Esq. speaks with Brian Lehman, Director, Medical Account Management and Strategic Alliances for Sandoz Inc. about everything Biosimilars – the current biosimilar marketplace, PBMs and biosimilars, and opportunities in the biosimilar marketplace.

Ron Lanton: How have recent FDA policies affected the biosimilars marketplace?

Brian Lehman: My perspective from working with pharmacy benefit managers (PBMs), health plans and employer groups, these stakeholders would benefit from being included in the U.S. Food and Drug Administration’s (FDA) biosimilar education and outreach efforts geared towards patients and the providers who treat them. We included this suggestion in our comments to the FDA Notice of Hearing entitled Facilitating Competition and Innovation in the Biological Products Marketplace.

The need remains for additional FDA-driven, educational efforts to enhance biosimilar understanding among these groups. Doing so could benefit decision making on formulary and utilization management programs.

The FDA has stringent requirements and regulations for the development and approval of all reference biologics and biosimilar medicines.1 The FDA’s authority has the power to help increase payers’ confidence that a biosimilar matches the reference biologic in terms of safety, efficacy and quality via rigorous development and testing processes.

The economic impact for real-world evidence and simulation models is compelling.  Approximately $100 billion worth of biologics are expected to be off patent by 2020, which present a substantial opportunity for biosimilar medicines to create savings for the US healthcare system[i]. Biosimilars may help to provide millions of patients with more affordable and accessible treatment options. They create the potential to save the US healthcare system an estimated $54 billion over 10 years[ii].

 

RL: What types of obstacles are there for biosimilars in the marketplace?

BL: Only 1 in 18 biosimilars in the U.S. market is currently a success story, and that’s Sandoz Zarxio® (filgrastim-sndz) – the first biosimilar to surpass its reference biologic in market share[iii].  To that end, several health systems, integrated delivery networks and payers have realized savings when switching to Zarxio – including Yale New Haven Health System, Robert Wood Johnson Barnabas Healthcare System and Carolina Blood and Cancer Care[iv],[v],[vi],[vii]. Many obstacles for biosimilars in the U.S. exist along the path that begins with discovery and development; continues with the process of obtaining regulatory approval; and ends with patients accessing their biosimilar for treatment. Of those 18 FDA-approved biosimilars, only seven are available for use.

We’ve observed significant obstacles barring biosimilar medicines getting to market, which hinders patient access and is detrimental to healthcare savings.

It is beyond time that all stakeholders work together to overcome the gridlock and provide additional incentives so more patients can access these important medicines.

 

RL: Will doctors or PBMs be the deciding factor for how fast biosimilars make it into the market?

BL: All stakeholders play a significant role in fast-tracking the adoption of biosimilars into the US healthcare system. Actions taken by providers, professional societies, payers, healthcare plan administrators, patients and policy makers send signals back to manufactures on why it is important to continue investing in biosimilars.  Positive signals in support of biosimilars and removal of barriers will favorably impact how the US is able to realize savings in healthcare spending and improvements in patient access – now and for the future.

In order to increase support of biosimilars, we need a multi-channel approach focused on amplifying education. The FDA, along with professional organizations, patient advocates and manufacturers play an essential role in educating our community about biosimilars to help earn an equitable level of trust that they expect with reference biologics.

 

RL: With increasing political scrutiny on high-priced medications such as insulin, are there opportunities for biosimilars within this space?    

BL: Yes- there is a clear unmet need for people with diabetes. Each year, 1.4 million Americans are diagnosed with diabetes. Approximately six million Americans with diabetes use a form of insulin[viii]. Among adults diagnosed with diabetes, some may struggle to afford their insulin, putting them at risk of disease-related complications that drive up healthcare costs.

The good news is that the FDA released guidance to help reframe the narrative. Starting in March 2020, medicines that include insulins will be regulated as biologics versus drugs or small molecules. This will allow manufacturers to file for approval of their insulin medicines via the biosimilar similar pathway. That makes a big difference because currently it is not possible to submit an application for a biosimilar to insulin in the US – a transformative move to promote competition[ix].

We hear a lot about the problem of skyrocketing healthcare costs, but very few are doing something about it. The future of insulin biosimilars will be significant due to the increase in competition that will help bring down prices for patients and the healthcare system.  Anticipating the growing needs for insulin biosimilars, Sandoz entered into an agreement to commercialize biosimilar versions of insulins used in patients with type 1 and type 2 diabetes. (Press release source: https://www.sandoz.com/news/media-releases/sandoz-enters-commercialization-and-supply-agreement-insulin-biosimilars). This will ultimately result in increased access, adherence and reduced complications for individuals who use insulin.

*Zarxio and Erelzi are registered trademarks of Novartis AG.

 

References:

[i]GBI Research. $100 billion of revenues up for grabs for drug manufacturers by 2020 as patents for key biologics expire [press release]. March 13, 2017. https://drug-dev.com/100-billion-of-revenues-up-for grabs-for-drug-manufacturers-by-2020-as-patentsfor- key-biologics-expire/. Accessed December 14, 2018.

[ii]Mulcahy AW, Hlávka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Santa Monica, CA: Rand Corporation, 2017. Available at: https://www.rand.org/pubs/perspectives/PE264.html.Accessed February 27, 2019.

[iii]IMS Health Institute for Healthcare Informatics. Delivering on the potential of biosimilar medicines: the role of functioning competitive markets. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/delivering-on-the-potential-of-biosimilarmedicines.

pdf?la=en&hash=7705453CF0E82EF41402A87A44744FBF8D84327C&_=1518722219951. Accessed December 14, 2018.

[iv]Evans M. Barnabas and Robert Wood Johnson sign deal to form biggest New Jersey health system. Modern Healthcare Website. Available at: http://www.modernhealthcare.com/article/20150714/NEWS/150719965. Published July 14, 2015. Accessed October 5, 2018.

[v]Data on file. RWJBH Raw Sales Data. Sandoz Inc. March 2018.

[vi]Davio K. Oncologist sees biosimilars playing a role in the oncology care model. The Center for Biosimilars Website. Available at: http://www.centerforbiosimilars.com/news/oncologist-sees-biosimilars-playing-a-role-in-the-oncology-care-model. Published April 12, 2018. Accessed June 11, 2018.

[vii]Leber MB, Abdelghany O, Miller L. Biosimilar adoption: health system challenges and strategies for success. Poster presented at: 2016 Vizient Clinical Connections Summit, Dallas, TX, September 29, 2016.

[viii]American Diabetes Association. Fast Facts: Data and Statistics about Diabetes. Available at: https://professional.diabetes.org/sites/professional.diabetes.org/files/media/fast_facts_12-2015a.pdf. Accessed February 27, 2019.

[ix]US FDA. Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628121.htm. Accessed February 27, 2019.

Don’t Ignore the Steady Drumbeat of Drug Importation

This article was originally posted on Specialty Pharmacy Times.

We are living during a time in which we are witnessing the possibilities of curative medications and their significant improvement on patient outcomes. However, these breakthroughs have come at the price of higher-cost medications, leading to a vigorous debate about the value of improved outcomes in terms of time and spending.

One way that policymakers and industry insiders have constantly considered to lower drug prices has been through importation. This would theoretically lower drug prices by allowing market players from outside the United States to compete. Although this idea is intriguing, there undoubtedly are obstacles, such as safety concerns and federal law. However, this has not stopped the recent activity we have seen in Congress and on the state level.

Let’s consider the latest policy ideas on the subject of importation.

First, let’s examine the current law for importation, as this subject depends on whether a medication is manufactured as an unapproved drug versus an unapproved drug imported via a consumer. The FDA’s enforcement on unapproved medications intended for commercial use is evident within its guidance. The United States Federal Food, Drug, and Cosmetic Act prohibits interstate shipment of unapproved new drugs, including importation. The act allows the FDA to refuse admission of any drug that “appears” to be unapproved, which forces the importer to prove the desired drug has been approved by the FDA or be subject to FDA enforcement actions.1

However, the FDA’s viewpoint on personal importation of unapproved drugs is different, with several factors considered by agency personnel when determining whether to enforce the act or take action against the importer.

The FDA will allow importation of a drug when its intended use is unapproved for a serious condition that does not have an effective treatment available domestically through commercial or clinical means, there is no known commercialization or promotion to US residents by distributors of the drug, the drug is not considered to pose an unreasonable risk, and the individual seeking to import the drug affirms in writing that it is for personal use—typically in quantities under a 3-month supply—and provides the name and address of the US-licensed doctor responsible for treatment or proof that the drug is for the continuation of a therapy that began in a foreign region.

Thus, although the FDA does have preferences on commercial versus personal importation of unapproved prescription drugs, the law is flexible on allowing for certain situations.

Recently, the FDA weighed in on the idea of importation. FDA Commissioner Scott Gottlieb, MD, who has been very aggressive in implementing new policies in an attempt to lower costs across the supply chain, last year announced a new working group that would examine importation. Gottlieb’s approach is to consider importation through the lens of alleviating drug shortages from single-source manufacturers.

“We want to examine whether, under these narrow conditions, the additional market competition from the short-term importation of foreign versions of the drug may complement the FDA’s current efforts and help meet near-term patient need in the [United States] until new competition is able to enter the domestic market,” Gottlieb wrote in a statement on the FDA website in July 2018. “To pursue these considerations, we’re forming a work group to explore various policy frameworks that, through the exercise of enforcement discretion or otherwise, would involve the importation of drugs under circumstances that meet these criteria and that would be suitable substitutes for the FDA-approved version of the medically necessary drugs. We will consider whether and how the foreign versions of these medicines can be imported with adequate assurances of safety and effectiveness.”2

Gottlieb added that a policy involving importing drugs would be a temporary measure until adequate competition enters these categories and any resulting policy would need to be structured to eliminate the risk of counterfeit or unsafe drugs entering the US supply chain.

Congress already has a few initiatives on importation:

• The Affordable and Safe Prescription Drug Importation Act would instruct the HHS secretary to issue regulations allowing wholesalers, licensed US pharmacies, and individuals to import qualifying prescription drugs manufactured at FDA-inspected facilities from licensed Canadian sellers. After 2 years, the secretary would have the authority to permit importation from countries in the Organisation for Economic Co-operation and Development that meet specified statutory or regulatory standards that are comparable to US standards. The bill would not permit importation of controlled substances, anesthetic drugs inhaled during surgery, or compounded drugs.

• The Safe and Affordable Drugs from Canada Act would permit the importation of prescription drugs from approved pharmacies in Canada.

• If enacted, HR 447 would allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals.