The recently introduced Bill HR 1245 IH, the ‘‘Affordable and Safe Prescription Drug Importation Act’’ attempts to open the door to lower cost drugs via Canadian pharmacies.1 This bill is not intended to be a follow up to the as yet fully enacted Drug Supply Chain Security Act (DSCSA signed November 2013) but its very nature binds the two pieces of legislation. Apparently the authors of this recent bill are not fluent with the problems being addressed by DSCSA.
The bill focuses on importation from Canada, which implies that the authors are unaware of the global counterfeiting problem. The reference to legitimate internet pharmacies confirms this concern.
Excerpts from a 2012 WebMD article provide insight. “Fake online pharmacies are an emerging health threat, the FDA warns. The FDA points to a recent study by the National Association of Boards of Pharmacy, which represents the state agencies that license U.S. pharmacies. Of the 10,065 online pharmacies in the NABP study, 9,734 – 97% – violated state or federal laws and/or NABP safety and practice standards. Noting that 97% of online pharmacies are illegal in the U.S., the FDA has begun a campaign to warn consumers about what it sees as an emerging threat.”2
This staggering statistic calls into question legislation suggesting importation via internet pharmacies to reduce prescription drug costs for U.S. customers. As for the Canadian sourcing referenced several times in the legislative draft, consider the following points called out by SafeMedicines.org.3
Facts about importing drugs from Canada
- Drugs from Canada don’t always come from Canada … up to 70% of drugs sold to Americans from Canada are made elsewhere…
- There isn’t enough supply in Canada to satisfy U.S. demand…
- The Canadian regulators don’t think (internet pharmacies) are a good idea. … In 2008, Manitoba regulators announced they will stop licensing internet pharmacies, because they could not oversee operations when customers all live in another country.
- Canada isn’t going to carefully scrutinize drugs bound for the United States. By marking the drugs “for export only,” drug exporters can bypass Canada’s safety regulations and mail fake or low-quality drugs made in China, India and other countries notorious for ineffective and sometimes deadly products…
- Canadian pharmacies are not subject to the FDA’s jurisdiction. … In 2003, CanaRX was warned by the FDA to stop providing Americans with medications because they were obtaining medications from unapproved suppliers and shipping refrigerated medications using plain mail services.
The Drug Supply Chain Security Act (DSCSA) is intended to remedy concerns outlined. DSCSA legislation focuses on peer to peer transfer of products and serialized container data to thwart counterfeit introduction. Opening our market to Canadian pharmacies (including internet) undercuts DSCSA safeguards.
So, is this legislation DOA (dead on arrival)? Does it undermine the safety of pharmaceuticals by allowing via legislation the importation of pharmaceuticals through channels that FDA and regulatory bodies cannot monitor or police? Not entirely.
Both this new bill and DSCSA could be improved by adding one change to the delivery methods. Provide pharmaceuticals as the rest of the world does, unit dose blisters packed by the original manufacturer. The one glaring omission from DSCSA is the manufacturers’ container does not travel to the patient. Serialized bulk packages will be a great improvement over current packages. Serialized unit of use that reaches the patient is better still.
Now, to be clear, not all countries require the peer to peer communication that DSCSA includes. Without that communication there is concern that bad actors in the supply chain could have time to copy packaging and even duplicate serial numbers. This is a valid concern but only time will tell if that weakness in foreign plans will keep the door open for counterfeiters.
Regardless, this path would be the only way to safeguard product importation being promoted under HR 1245 IH. Without this step we are opening the door to counterfeit and gray market drugs that DSCSA was intended to close.
The Healthcare Compliance Packaging Council is a nonprofit trade association whose primary mission is the greater use of compliance-prompting packaging to improve patient adherence and patient outcomes, leading to reduced healthcare costs.
Learn more information on HCPC, please visit hcpconline.org.