{"bills":[{"photos":{"featured":"https://assets.causes.com/bill/photo/s97-116/featured_affordable-and-safe-prescription-drug-importation-act-1566596815.jpg","featured_large":"https://assets.causes.com/bill/photo/s97-116/featured_large_affordable-and-safe-prescription-drug-importation-act-1566596815.jpg","shareable":"https://n.causes.com/share-images/bills/s97-116.png"},"introduced_on":"2019-01-10","title_override":"Should American Patients be Allowed to Import Lower-Cost Prescription Drugs From Overseas?","summary_override":"

This bill — the Affordable and Safe Prescription Drug Importation Act — would instruct the Secretary of Health and Human Services to put forward regulations allowing wholesalers, pharmacies and individuals to import qualifying prescription drugs from licensed Canadian sellers. After two years, the secretary would have the authority to permit importation from countries in the Organisation for Economic Co-operation and Development (OECD) with standards for the approval and sale of prescription drugs that are comparable to those in the U.S.

In order to ensure consumer safety, this bill includes provisions for FDA certification of foreign sellers, clearly defines what types of drugs may be imported, and sets requirements for supply chain security. Specifics of those provisions are outlined below:

IMPORTATION OF NON-COMPOUNDED DRUGS ONLY & LIMITATIONS ON BIOLOGICS

Legally imported drugs under this bill would be required to be purchased from an FDA-certified foreign seller and have the same active ingredient, route of administration and strength as drugs approved in the United States. Certain types of drugs, such as certain biologics, could only be imported by wholesalers or pharmacies. This bill would not permit importation of controlled substances, anesthetic drugs inhaled during surgery, or compounded drugs.

REQUIREMENTS FOR “CERTIFIED FOREIGN SELLER” STATUS

To be a “certified foreign seller,” an entity would have to be a wholesale distributor or licensed foreign pharmacy, be current with any applicable registration fees, and sell only qualifying prescription drugs.

Certification criteria would require the establishment to:

Be located in Canada;
Be engaged in the distribution of prescription drugs offered for importation under this bill;
Have been in existence for at least five years and has a purpose for existing other than for this program
Only sell to individuals after receiving a valid prescription
Certify that the physical premises and data reporting procedures and licenses are in compliance with all applicable laws and regulations in Canada, and has implemented policies to monitor compliance;
Conduct ongoing and comprehensive quality assurance programs, including blind testing;
Agree to use laboratories approved by the HHS Secretary to test product samples;
Agree to notify the Secretary, importers, and individuals of product recalls;
Have a process for resolving grievances and will be held accountable for violations of established rules;
Not sell products to U.S. customers that are illegal in Canada; and
Meet any other criteria established by the Secretary.

Certified foreign sellers would also be required to undergo recertification every two years or until there is a material change in circumstances and pay a fee (to be determined by the HHS Secretary) to fund the administration and enforcement of the drug importation program.

LIMITATIONS ON INDIVIDUALS IMPORTING PRESCRIPTION DRUGS

This bill would limit who can import prescription drugs from overseas. It’d require that such individuals only purchase for personal use in quantities that don’t exceed a 90-day supply, have a valid prescription issued by a U.S. health care practitioner, and only import from pharmacies licensed to practice pharmacy and dispense drugs in Canada.

\t\t\t

REPORTING REQUIREMENTS FOR DRUG IMPORTERS

Under this bill, drug importers would be required to submit biannual reports to the HHS Secretary detailing the drugs they are purchasing from certified foreign sellers, including the name, strength and dosage form, number of containers and container size, lot number, date of the transaction and shipment, business names and addresses of seller and purchaser, and the unique facility identifier where the drug was manufactured.

SUSPENSION OF IMPORTATION

This bill would grant the HHS Secretary authority to suspend the importation of a product or suspend all products from a certified foreign seller or importer if there is an importation involving counterfeit drugs, drugs that have been recalled or withdrawn, or drugs in violation of any requirement of this section until an investigation is completed and the Secretary determines that the drug, seller, or importer does not endanger the public health. The Secretary would have to suspend a product or all products from a seller or importer if there is a pattern of such violations.

PROHIBITION ON DELAYING IMPORTATION OF QUALIFYING DRUGS

Except in the case of a drug shortage, the bill would prohibit drug manufacturers from directly or indirectly engaging in actions to restrict, prohibit, or delay the importation of qualifying drugs under this program.

REPORT TO CONGRESS ON PROGRAM’S EFFICACY

The HHS Secretary would be required to issue a report to Congress and the public on this program no later than a year after this bill’s passage. Additionally, the Government Accountability Office (GAO) would be required to conduct a study to analyze the implementation of the Act, including a review of drug safety and cost-savings and expenses, including cost-savings to consumers in the United States and trans-shipment and importation tracing processes, within 18 months of this bill’s passage.

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Patients whose drugs are cheaper outside the U.S. should be allowed to buy their drugs from there in order to keep their healthcare costs as low as possible. Reducing prescription drug costs for patients will save lives and reduce the cost of health care in the U.S. — both noble goals worth pursuing through federal policy.","argument_against":"Pharmaceutical companies need the revenue from their sales in the U.S. to fund innovative research that saves lives. Additionally, allowing personal importation from other countries might lead to unsafe or counterfeit medication entering the U.S., putting patients’ lives at risk. Finally, the FDA and HHS have already released a plan allowing states to develop pilot importation programs. 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Should American Patients be Allowed to Import Lower-Cost Prescription Drugs From Overseas?