Enforcement Actions Targeting Prescription Drugs For Personal Import Should be Limited to Unsafe or Counterfeit Medications
Despite federal restrictions, five million Americans import medication for personal use each year because the cost of medication in the U.S. is too high. Section 708 of the Food and Drug Administration Safety and Innovation Act of 2012 expanded FDA’s authority to destroy personally imported medications confiscated at international mail facilities.
FDA should not use its authority to deprive patients of access to prescribed, safe and effective medications. Millions of Americans import lower cost medication traveling to Canada and Mexico, ordering from international online pharmacies, or through U.S. based programs connecting them with international pharmacy options. The safest international pharmacy options should not be the target of enforcement actions, as they offer a lifeline of affordable medication.
FDA should focus enforcement actions only against rogue operations, i.e., those which do not require a prescription, intentionally sell counterfeit or adulterated drugs and do not fill orders through licensed pharmacies that are dispensed by licensed pharmacists.
Medicare Should be Permitted to Negotiate Drug Prices
Using their bargaining power to get the best drug prices for their citizens, governments in all other advanced economies set or negotiate drug prices. The Centers for Medicaid & Medicare should be allowed to negotiate drug prices with pharmaceutical companies to bring down taxpayer and consumer costs for Medicare enrollees.
To achieve this goal, prohibitions against such negotiations put in place under the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) must be lifted. Medicare’s Part D, a product of the MMA, was helpful in bringing drug price relief to millions of seniors, but millions are still not taking medications due to cost.
Letting Medicare negotiate will enable seniors to get the “bargaining” they need to afford medications.
“Pay-to-Delay” Should be Ended
Drug companies should be prevented from conspiring to prevent lower cost generics from coming to market. “Pay to delay” deals involve payment by a brand-name company to a generic drug company to delay marketing a generic version that has obtained FDA approval to market in the United States. The Federal Trade Commission estimates that taxpayer drug costs were $3.5 billion higher in 2014 because of such deals. Pay to delay deals should be banned.
Importation of Lower-Cost, Safe and Effective Drugs Should be Permitted
People often talk about whether or not to “legalize” drug importation. That’s not the right word. Drug importation is already legal in the U.S. According to the FDA, 40% percent of prescription drugs we purchase in U.S. pharmacies are imported and 80% of their active pharmaceutical ingredients, the main ingredients found in drugs, are imported. The importers are usually drug manufacturers and wholesaler distributors.
However, individual consumers in the U.S. don’t have the same right to import their medication from a pharmacy in Canada or another country, which impedes their access to affordable medication. On average, among the richest countries, medications outside the U.S. cost 50% less but the price discrepancies go as high as 99%!
Pharmacies in the U.S. are not allowed to import lower-cost, FDA-approved pharmaceuticals from wholesaler in Canada or other countries. Allowing them to do so would mean lower prices at U.S. pharmacies.
We need laws that protect our drug supply, not import restrictions that profit pharmaceutical companies at the expense of American consumers. Laws and regulations should be reformed to remove unnecessary import restrictions on lower-cost pharmaceuticals, better ensure product safety and protect against counterfeit drugs.