lunes, 20 de marzo de 2017

FDA Law Blog: Oh Canada! Drug Importation Bills Look North to Address Accessibility and Cost

FDA Law Blog: Oh Canada! Drug Importation Bills Look North to Address Accessibility and Cost



Posted: 17 Mar 2017 12:37 PM PDT
By Sara W. Koblitz –

Oh Canada! Congress has decided that it’s once again time to start looking to our neighbor’s to the north for some help increasing accessibility and decreasing cost of prescription drugs.  With two new bills introduced in the last month, one in each chamber of Congress, it seems that congressional Democrats are hoping to import more than just hockey and Tim Horton’s from Canada.   

On February 28, 2017, Senators Bernie Sanders, Cory Booker, and Bob Casey introduced S. 469, the “Affordable and Safe Prescription Drug Importation Act.” (A companion bill was introduced in the House of Representatives – H.R. 1245 – by Representative Elijah Cummings.) Designed to help lower the cost of prescription drugs by allowing Americans to import medicine from Canada, S. 469 would amend FDC Act § 804 to direct FDA to promulgate regulations facilitating the importation of “qualifying prescription drugs” from “certified foreign sellers” in Canada and other permitted countries into the U.S.  The bill has lengthy definitions of “qualifying prescription drugs” and “certified foreign sellers,” but in short, the bill allows importation of drugs approved in Canada that comply with FDA GMPs (other than controlled substances, inhaled drugs for surgery, and compounded drugs) to be imported foreign wholesale distributors or licensed pharmacy operators certified by FDA to meet certain conditions. Eventually, FDA may open up importation of drugs from OECD countries with comparable legal standards for approval. 

H.R. 1480, introduced in the House of Representatives by Chellie Pingree of Maine as the “Safe and Affordable Drugs from Canada Act of 2017,” introduces similar, but much less detailed legislation. H.R. 1480 amends the FDC Act to permit for importation a 90 day or less supply of prescription drugs from Canada for personal use only.  The drugs must be purchased from an approved and certified Canadian pharmacy with a valid prescription from a health care provider licensed in the U.S.  More products are excluded under H.R. 1480 than S. 469, as H.R. 1480 explicitly excludes controlled substances, biologics, infused drugs, intravenously injected drugs, inhaled drugs for surgery, parenteral drugs, biotechnology-processed products (i.e. therapeutic DNA plasmid products, monoclonal antibody products, therapeutic synthide peptic products with fewer than 40 amino acids, and recombinant DNA-derived products), and refrigerated products from importation.  Senator John McCain’s S. 92, an almost identical bill, was introduced in the Senate in January 2017.

While both bills introduce some questions about supply chain accountability, they both reflect a fairly simple way to reduce drug prices while the rest of Congress fights it out over coverage. Similar efforts have failed in the past (see Sen. McCain’s version introduced in 2015 that went nowhere), but with the Congressional Budget Office projecting that millions of Americans may become uninsured with the repeal of the Affordable Care Act, this bill might see some action this year. Like we’ve had to say a lot this year: we’ll just have to wait and see what happens. . . . Eh?