Within the past two months, the online pharmacy marketplace has experienced some market-shifting dynamics that could alter the scope and direction of the industry. Within the span of approximately two weeks, e-commerce behemoth Amazon announced the launch of its NABP-accredited pharmacy website against the backdrop of Food and Drug Administration’s (FDA’s) Importation of Prescription Drugs final rule becoming effective.
The two updates highlight the growing chasm in the online pharmacy environment and continued threat to public health and patient safety by those who solely seek profit. With the entrance of Amazon Pharmacy comes a safe and legitimate source of prescription drugs via the internet, and an opportunity to raise the visibility of accredited pharmacies operating legitimately and within the confines of the law.
On November 30, 2020, FDA’s final rule regarding prescription drug importation went into effect, paving the way for the federal government to review importation proposals submitted by states for their constituents. On November 23, Florida Governor Ron DeSantis announced that the state had submitted its importation proposal to the United States Department of Health and Human Services (HHS) through the state’s Agency for Health Care Administration, despite having received no bids on its $30 million contract solicitation to operate the program. It is anticipated that in the coming weeks and months, several other states far along in this process will submit proposals to HHS for review, including New Mexico and Colorado.
Preempting the effective date of the final rule, however, Health Canada and Minister Patricia Hajdu announced the promulgation of an interim order on November 28, targeting potential drug shortages caused by the export of prescription medicines to foreign countries. The order notes that effective immediately, domestic drug wholesalers would be prohibited from exporting any prescription drug that may lead to or further worsen a shortage. Stakeholders such as ASOP Canada applauded the efforts as an opportunity to help ensure the integrity of Canada’s domestic supply chain and promote the safety and well-being of its citizens.
Having formally launched on November 17, the Amazon Pharmacy platform provides patients and caregivers with an opportunity to purchase prescription drugs through the website in a safe and secure transaction. Coupled with existing insurance information, users will have the ability to manage prescriptions and decide between methods of payment (eg, insurance co-pay or cash pay). Additional incentives are available for Amazon Primemembers. The fully digital service will provide users 24/7 access to licensed health care providers and shift focus increasingly toward the new setting of care: the home.
Amazon’s investment into the pharmacy industry may be further augmented by the company’s recent announcement of a partnership with the National Intellectual Property Rights Coordination Center (IPR Center). Through “Operation Fulfilled Action,” the partnership aims to combat the entrance of counterfeit goods into the US and to leverage data to supplement ongoing investigations. While time will tell, a hopeful outcome of this pilot could better inform the screening of packaging at the borders and provide US customs and postal service officials with valuable tools to ensure domestic safety and security. A familiar interagency partnership to NABP and online pharmacy allies, the IPR Center remains a leader in the efforts to combat illegal online drug sales and an advocate for greater WHOIS data transparency under the leadership of Director Steve Francis.
2021 will undoubtedly be an exciting time for the legitimate online pharmacy marketplace, NABP’s .Pharmacy Verified Websites Program, and pharmacy practice and policy more broadly. While the entrance of Amazon into this industry marks a great opportunity to provide legitimacy in a marketplace prone to fraud and criminality, consumers, health care providers, policymakers, and patients must remain vigilant in understanding what distinguishes a legitimate pharmacy from a fake one. The announcement of a major new online pharmacy platform coupled with the promise of “safe drugs from Canada,” may cause American patients to turn to the internet for affordable drugs, unknowingly finding themselves seeking care from unlicensed websites rather than a .pharmacy-verified platform. Educating patients and providers about the specter of illicit online pharmacies while directing them to safe ones must remain a priority in the new year.