Issues Surrounding the Importation of Prescription Drugs in the US

CASE STUDY: IMPORTING DRUGS TO US

Case Study: Importing Drugs to US

7-3: Should the United States legalize the importation of lower cost pharmaceuticals? If so, should this apply to individual consumers, pharmacies, or other entities?

The US should legalize the importation of lower-cost pharmaceuticals from selected countries with testing and licensure requirements similar to those of the FDA. Strict conformity to US standards for handling and manufacturing prescriptions would ensure that Americans are protected from unsafe medication. Importation would also lower drug prices for American consumers as assessments have indicated that prescription drugs in countries like Canada retail at between 40 and 60 percent less than in the US (XXX). Ultimately, this would result in significant cost savings for individual customers as well as private and public payers. For instance, the state of Florida projects that its importation program would save the state between $80 and $150 million in prescription expenses annually (Freed et al., 2021).

Current importation laws only allow pharmaceutical companies to import drugs into the US. In essence, this means that manufacturers set their own drug prices in the American market. However, this creates a monopoly among manufacturers that limits price competition and encourages price gouging (XXX). For instance, the case demonstrates how Turing Pharmaceuticals purchased and increased the price of the drug Daraprim from $13.50 to $750 overnight. A more beneficial importation plan would allow pharmacists and wholesalers to also import pharmaceuticals from pre-determined countries subject to the FDA’s safeguards and standards. This would eliminate the monopoly that manufacturers enjoy as sole importers and encourage price competition. Allowing individuals to serve as importation agents may be detrimental as it would impose a huge burden on the FDA in terms of ensuring safety and would make it difficult to control domestic medication prices. Moreover, allowing individual importers may make it more challenging for manufacturers to track their drugs in the market, which would increase the risk of counterfeiting (Freed et al., 2021).

7-6. If the United States were to permit importation of lower-cost pharmaceuticals from abroad, should this apply to all pharmaceuticals or just to some? If just to some, what criteria should be used?

The United States needs to permit importation of just some pharmaceuticals as opposed to all for two major reasons. First, fewer pharmaceuticals will be easy to manage and ensure high levels of effectiveness in ensuring safety. Opening up only a few pharmaceuticals to importation would make it more manageable for the FDA to effectively ensure that all safety standards and regulations are met. Secondly, a situation where all pharmaceuticals are imported may significantly add to the workload of the FDA and the agency may be forced to increase staffing levels or increase fees and licenses for importers. Ultimately, the additional costs would be passed on to consumers, thus eroding the cost savings that would otherwise have been realized.

The FDA could set the standard that only drugs that are currently marketed in the US would be eligible for importation. Current law excludes certain drugs and biological products from importation including drugs inhaled during surgery, intravenously injected drugs, infused drugs, biological products such as insulin, controlled substances, and drugs such as opioids that are classified under the FDA’s Risk Mitigation and Evaluation Strategies (REMS) for posing serious safety concerns (Freed et al., 2021). These drugs could be excluded from importation, due to their associated safety concerns. Any other drugs that is currently marketed in the US market could be imported for use by patients.