Ensuring the Integrity of the
Global Supply Chain
From the beginning of COVID-19, CHPA and members of the pharmaceutical supply chain have been concerned about the availability of critical medical supplies and ingredients.
CHPA teamed up with representative organizations of the pharmaceutical supply and payment chain to ensure patients have access to essential medicines during COVID-19. Partners included:
- pharmaceutical brand and generic manufacturers
- wholesalers
- retail, specialty, managed care, and hospital-based pharmacies
- health insurance providers and other payers
- pharmacy benefit managers
CHPA worked with government authorities to help establish OTC and supplement manufacturing facilities as essential industries, allowing them to continue to produce important self-care products during the pandemic.
Prop 65
OEHHA Adopts Amendments to Prop 65 on Responsibility for Providing Product Warnings
OEHHA has adopted amendments to Article 6 Clear and Reasonable Warnings Regulation to provide more specific guidance to businesses regarding their responsibilities to provide consumer product exposure warnings for chemicals listed under Prop 65. The regulation came into effect on April 1, 2020.
CHPA Comments on California Office of Environmental Health Hazard Assessment Prioritization of Chemicals
In joint comments submitted to OEHHA regarding a Prop 65 notice of prioritization for 22 chemicals, CHPA along with the Personal Care Products Council (benzophenone-3; parabens, and titanium dioxide-nano form) and the Council for Responsible Nutrition (manganese), recommended a low priority for each of these ingredients. At a December meeting, benzophenone-3 was the only ingredient given a high priority for review. It is unlikely that a substance with a priority less than ‘high’ will come up for listing consideration as a reproductive toxicant under Prop 65 for at least 5-10 years.
CBD
CHPA called on the U.S. Food and Drug Administration (FDA) to swiftly issue regulations establishing a clear pathway for responsible manufacturers to lawfully market dietary supplement products containing CBD.
Such a pathway would put in place necessary safeguards to protect public health while also giving stakeholders a mechanism to provide much-needed safety data. In the absence of action by FDA, however, CHPA has called on Congress to act, and we were pleased to see the introduction of bipartisan legislation to create a regulatory pathway for this promising dietary ingredient.
Environmental Sustainability
CHPA has formed a new Environmental Sustainability Working Group. Based on a recent survey of our board of directors, members are interested in learning about best practices, sharing information, and benchmarking, as well as hearing about CHPA efforts to advocate for our industry in light of state and federal regulatory/legislative actions and proposals.
Please email Barb Kochanowski if you have questions or are interested in participating.
Loperamide
In 2017, CHPA members who manufacture and market loperamide-containing products established a task group in response to concerns of abuse and misuse of this anti-diarrheal ingredient. In 2019, FDA and industry announced packaging changes to loperamide. Solid forms of OTC loperamide would be sold only in unit-dose packaging (blister packs), with a maximum of 48 milligrams of loperamide per pack (24-count pack size). Liquid products would be sold in 4-ounce and 8-ounce sizes, with no more than 32 milligrams of loperamide in 8 fluid ounces.
In 2020, these packaging changes were implemented market-wide, both online and in stores. CHPA continued to work alongside numerous national professional and patient organizations — like the American Association of Poison Control Centers (AAPCC) and the American Society of Clinical Toxicology (ASCT) — to balance abuse prevention efforts with the critical need to maintain OTC access to this essential anti-diarrheal medicine. So far, the digital and grassroots campaign LoperamideSafety.org has reached more than 20 million healthcare professionals, the website has hosted 33,000 healthcare visitors, and more than 7,000 at-risk consumers looking for information about loperamide safety.
Impurities in Drug Products
Manufacturers are ultimately responsible for preventing impurities in their drug products. Recently FDA has been investigating the presence of a group of impurities called nitrosamines, that were found in both prescription and OTC drug products. FDA is working with the industry to determine the source of these impurities (if any) in all drug products.
This is challenging because there are multiple reasons why nitrosamines can be present in drug products and the industry needs to develop methods to detect these impurities at very low levels. FDA and international health authorities have established acceptable daily intake limits for nitrosamines.
CHPA is working with other organizations to establish a coalition to provide feedback to FDA on approaches to ensuring the quality of the pharmaceutical supply chain.
Sunscreen Remains a Popular
Focus at the State Level
Students across the country are frequently required to show physician permission to be permitted to apply OTC sunscreen at school and school-sponsored events. Many state lawmakers, however, recognize the important health benefits of sunscreen and have introduced bills allowing students to use sunscreen products at school without prior approval.
Legislation was enacted in Virginia and Washington, DC this year and bills were also considered in five other states. To date, 26 states plus the District of Columbia have enacted these sunscreen access laws. Effective January 1, 2021, Hawaii became the only state in the United States that has banned the sale of sunscreen containing oxybenzone or octinoxate, claiming they have a negative impact on the health of the coral reef. The state attempted to broaden the ban to other sunscreen ingredients but was unsuccessful in doing so in 2020.
CHPA's Diversity, Equity & Inclusion (DE&I) Initiative
Following the murder of George Floyd and the civil unrest that followed, CHPA’s board of directors formed a DE&I Steering Committee to identify meaningful steps that industry can take to promote a more inclusive environment and support broader efforts toward equal justice, inclusion, and opportunity for all. The Committee's recommendations, developed with experts in the field, will begin to be implemented in 2021 and will be communicated broadly to membership.
Thank you to the DE&I Steering Committee Volunteers
CHPA staff has also organized an internal Inclusion, Diversity, Equality, and Acceptance (IDEA) Committee with more than half of the staff volunteering to join. We look forward to reporting more on the progress of these initiatives in the years ahead!
