Safe and Affordable Drugs from Canada Act of 2015 (HR 2228, 114th Congress)
What it does
Permits individuals to import specific prescription drugs purchased from an approved Canadian pharmacy.
HR 2228, amending the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), directs the U.S. Food and Drug Administration (FDA) to promulgate regulations to allow for the personal importation of prescription drugs from approved pharmacies in Canada.
A qualifying prescription drug must:
- Be purchased from an approved Canadian pharmacy for personal use by the individual, not for resale, in quantities that do not exceed a 90-day supply;
- Be dispensed by a licensed Canadian pharmacist;
- Be filled via a valid prescription issued by a licensed American physician; and
- Have the same active ingredient(s), route of administration, dosage form, and strength as an American-approved prescription drug.
Non-qualifying prescription drugs include:
- Controlled substance(s) as defined in section 102 of the Controlled Substance Act (21 U.S.C. 802).
- Biological products as defined in section 351 of the Public Health Service Act (42 U.S.C. 262).
- Infused drugs, which are drugs administered via a needle or catheter.
- Drugs that are inhaled during surgery.
- Parental drug, which are drugs injected under the skin or into a vein or artery, for example.
- Drugs manufactured through biotechnological processes, including:
- Drugs that need to be refrigerated any time during manufacturing, packing, processing, or holding.
- Photoreactive drugs.
Under this bill, the promulgated rules would require the FDA to publish a list of approved Canadian pharmacies and their websites on the FDA website. Among other qualifications, an approved Canadian pharmacy is one that:
- Is located in Canada.;
- Is licensed to operate and dispense prescription drugs to individuals in Canada; and
- Has been operating for a period of at least five years before its approval for this program.
<p>Importing drugs from Canada is a proposed solution to high drug costs in America. Unlike the United States, Canada imposes price restrictions and limits on what pharmacies can charge for prescription medications.</p>
This bill’s regulations would prohibit the importation of all drugs manufactured using biotechnological processes. Biotechnology encompasses the range of tools that use or alter living systems to develop technologies and products for specific applications in medicine, agriculture, energy, manufacturing, and environmental protection.
One such biotechnology tool is to genetically engineer plasmid DNA to produce medically useful peptides or proteins which are not produced by the organism otherwise. This form of biotechnology explores how plasmid DNA could be used in therapeutic applications such as DNA vaccines and gene therapies; these applications could help treat many infectious, acquired, and genetic diseases.
Synthetic peptides are short polymers formed by stringing less than fifty amino acids together based on recombined DNA by processes of transcription and translation. These products can be used in drug delivery or have therapeutic effects themselves.
Another tool, recombinant DNA technology, creates new DNA sequences by joining or combining DNA fragments from different sources. This is commonly done by cutting DNA molecules with restriction enzymes and joining fragments from different sources with an enzyme called DNA ligase. Different types of DNA fragments can be glued together to produce a wide variety of products.
Endorsements & Opposition
- Senator John McCain (R-AZ), as quoted by The Senior Citizens League, says this bill will “spur much-needed competition in the pharmaceutical market and save individual Americans up to hundreds of dollars a year.”
- In a letter to House Speaker Paul Ryan (R-WI-1), the National Retiree Legislative Network expresses their disappointment that the Speaker has “not convinced the Republicans on the House Energy and Commerce committee to pass H.R. 2228, the Safe and Affordable Drugs from Canada Act of 2015.” The letter also states, “The need for [drug] importation arises in large part because U.S. drug companies sell into Canadian, European and other foreign markets where arbitrarily low pricing is set (price setting) by socialized health care systems.”
- At present, there has not been publicly reported opposition to this bill.