PhRMA remains committed to working with lawmakers to ensure patients can afford and access their medicines, but importation schemes that put patient safety at risk will never be the right approach.
In response to the Florida Agency for Health Care Administration’s request for information, PhRMA submitted formal comments to reiterate the biopharmaceutical industry’s concerns with HB 19.
Here are a few key excerpts:
Risk to Public Health and Safety: “If Florida’s intent is to limit imported medicines to those originally regulated by Health Canada, all interested vendors should be required to show evidence of a Canadian supplier’s willingness to certify they will only export such drugs to Florida’s program. If vendor candidates are unable to make this certification, AHCA will have to assess a health and safety impact based on the assumption that imported medicines will be transshipped or regulated by countries other than Canada.”
Canada Cannot Be America’s Medicine Cabinet: “It is unlikely Canada would be able or willing to supply Florida with medicines they regulate for a number of reasons. The population of Canada is approximately 37 million, and the population of Florida alone is approximately 21 million. It is impossible for the Canadian supply chain to accommodate Florida’s prescription drug needs. Canada negotiates its drug prices with manufacturers at a national and provincial level for drugs dispensed to Canadians. There is no reason to believe that Canada will place the needs of Florida residents over the needs of Canadians.“
Transshipment and Counterfeit Medicines: “Drugs entering Florida through Canada could be transshipped from almost any country, which increases the likelihood of not only the mishandling of drugs (e.g., through temperature/humidity variations and contamination), but also counterfeiting, mistakes in repackaging, and deceptive packaging and relabeling practices. Canadian law does not prohibit the transshipment of drugs from any country – including those in the developing world – into Canada and then into the U.S.“
Significant Cost Savings Unlikely: “In the much smaller state of Vermont, with a population just over 623,000, the Department of Vermont Health Access determined that, “drug importation from Canada would not provide net savings to the state or individuals because Medicaid’s existing prescription drug rebate program already yields substantial savings.” Vermont estimated a 45% markup on the Canadian price of a drug just to cover extra costs to the supply chain as well as a profit margin for supply chain entities. The Vermont estimate is conservative, as it only estimates a 25% markup for additional costs borne by voluntary participants in the program’s supply chain.”
You can read the full comment letter here.