Washington, D.C. - September 25, 2020 - (The Ponder News) -- The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration took actions to help provide safe, effective, and more affordable drugs to American patients as part of the Safe Importation Action Plan, fulfilling the aspect of the July Executive Order on drug pricing to complete the rulemaking to allow states to import certain prescription drugs from Canada.
The final rule implements a provision of federal law that allows FDA-authorized programs to import certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public’s health and safety while achieving a significant reduction in the cost of covered products to the American consumer. The final guidance for industry describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
“Today’s action is an important part of FDA’s priorities to promote choice and competition. The Safe Importation Action Plan aims to clearly describe procedures to import drugs that would lower prices and improve access while also maintaining the high quality and safety Americans expect and deserve,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA will continue to assess and act on opportunities to increase competition in the prescription drug market and help reduce the cost of medicines.”
The rule allows states (including the District of Columbia and territories), Indian tribes and — in certain future circumstances — pharmacists and wholesalers, to submit importation program proposals to the FDA for review and authorization. An importation program can be co-sponsored by a state, Indian tribe, pharmacist or wholesaler. Referred to as Section 804 Importation Programs, these programs will be managed by the respective sponsor and any co-sponsors and authorized by the FDA to facilitate the importation of certain prescription drugs that are approved in Canada and, with appropriate labeling, meet the conditions of an FDA-approved drug application. Eligible prescription drugs would have to be relabeled with the required U.S. labeling and undergo testing for authenticity, degradation and to ensure that the drugs meet established specifications and standards. These programs will also have to demonstrate significant cost reductions of the covered products to the American consumer.
The final guidance describes procedures for a drug manufacturer to obtain a National Drug Code (NDC) for certain FDA-approved prescription drugs, including biological products and combination products, that were originally manufactured and intended for sale in that foreign country. The use of an additional NDC for these products may allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require. Prescription drugs, including biological products, imported under the pathway described in the final guidance could be available to patients in a variety of settings, including hospitals, health care providers’ offices or licensed pharmacies, and would include the FDA-approved labeling (including prescribing information).
The American Pharmacists Association (APhA) was not happy with the decision.
"APhA is disappointed that FDA would risk the safety and security of our nation's drug supply by creating a complex and convoluted program allowing legal importation of certain drugs from Canada. We believe FDA's new drug importation program is not a safe way to reduce drug prices—and puts patients at risk.
FDA's final rule jeopardizes patient safety by creating supply chain vulnerabilities that could potentially introduce counterfeit or unsafe drugs. It also undermines the Drug Supply Chain Security Act (DSCSA), which creates "track-and-trace" safeguards that do not exist in Canada. By commingling FDA-approved and imported versions in the marketplace, this program also creates pharmacy operation disruptions and product selection confusion and may limit patient access to medications by complicating insurance coverage and reimbursement at the pharmacy.
Given the additional steps in the supply chain, such as relabeling and laboratory testing requirements, additional reporting systems, and the fact that most high-cost drugs are excluded from the program, it fails to produce significant cost savings to American consumers.
Today's final rule threatens our drug supply by creating opportunities for mischief that could introduce unsafe drugs into the U.S. The lack of clarity around unknown, unproven cost savings does not justify jeopardizing U.S. supply chain integrity and patient safety," said Ilisa Bernstein, PharmD, JD, FAPhA, APhA Senior Vice President of Pharmacy Practice and Government Affairs.
APhA has long advocated against unsafe drug importation schemes that would allow the introduction of risky products into our secure U.S. drug supply chain. Together with colleague pharmacy organizations, countless concerned pharmacists, and consumers, we opposed the December 2019 proposed rule and emphasized to FDA that patient safety cannot be compromised. FDA failed to consider the thousands of comments that opposed finalizing this program. We will continue to explore ways to protect patients and the drug supply from the perils that importation may bring and to ensure patient safety is not compromised."
The American Pharmacists Association is the largest association representing all of pharmacy, bringing together practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians and others to support pharmacists' ability to deliver optimal patient care.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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