Liver International. 2016;36(7):925-928.
Generic Medications for Hepatitis C
Excerpt:
Importing Generic Medications for Personal use
The continued medication access limitations have driven large interest in personal drug importation of the generic formulations. The United States Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 331) prohibits the interstate shipment (including importation) of non-FDA-approved drugs. The FDA's concern is that some countries do not regulate or restrict the exportation of products, therefore patients who order medications from businesses located in such countries may not be afforded the protection and safety of either foreign or U.S. laws. Legislation in Congress has been proposed in the past to allow the re-importation of large quantities of brand-name prescription medications from Canada and other countries. However, these legislative proposals do not include provisions for sufficient resources for FDA inspections as well as testing to ensure that re-imported drugs meet the agency's standards for safety and effectiveness.
The FDA focuses its enforcement resources on medications shipped commercially (including small shipments solicited by mail-order promotions). The agency does not focus on medications personally carried or shipped by a personal non-commercial representative of a consignee (buyer) or shipped from a foreign medical facility where a person has undergone treatment. The Regulation Procedures Manual for FDA personnel[8] includes guidance entitled 'Coverage of Personal Importations' for when to refrain from taking action against illegal personal importation or 'enforcement discretion'. Such circumstances include: (i) the drug is to treat a serious condition for which effective treatment is not available in the US; (ii) no commercialization or promotion of the drug to US residents; (iii) drug is not considered to represent an unreasonable risk; (iv) the individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the drug is for the continuation of treatment begun in a foreign country; and (v) generally, not more than a 3-month supply of the drug is imported.
Personal drug importation is still illegal and the requirements and documentation described in the guidance does not represent a binding obligation by FDA personnel to allow personal importation. The goal of the guidance is to save FDA resources while allowing continuation of individual medical treatments initiated in a foreign country or allowing medical treatment sought by an individual that isn't available in the US. The guidance includes a warning that lower cost versions of medications available in the US are not covered under the guidance because the agency cannot verify the supply chain for the drugs imported and thus is as unreasonable risk.
Full-text on Medscape
This article was the negative argument to this one, also published in July's Liver International http://onlinelibrary.wiley.com/doi/10.1111/liv.13157/full
ReplyDeleteABSTRACT
Hepatitis C, hepatitis B, HIV, TB and malaria are the five major causes of infectious disease death worldwide. In a breakthrough that rivals the invention of penicillin, drugs that cure hepatitis C, with minimal side effects and high success rates, have reached the market, but, in what must be one of the greatest tragedies of modern times, these life-saving medications are not being deployed on a mass scale. Pharmaceutical patents are gifted to private corporations by governments for the dual purposes of protecting R&D expenditure and encouraging innovation. Unfortunately the monopoly pricing power these patents provision currently lacks adequate checks and balances, is open to abuse, and is quite clearly being abused. The sort of legislative changes required to deliver on the original goals of pharmaceutical patents will take years or even decades to eventuate. Parallel importation of generic medication offers hope to the millions of patients with HCV unable to afford access to vastly overpriced originator medications. Doctors prescribing and monitoring patients taking generics can take comfort from the fact that the REDEMPTION trial results show, like the HIV generics that came before them, that HCV generics deliver robust clinical results.