Tuesday, April 8, 2014
Proposed Section 708 Rules Promulgation On Seizures of imported medicines nears; Support petition to prevent unwarranted seizures, Denial of lifeline of vital medicines to Americans
One of the most potentially troublesome portions of S. 3187 (FDA Safety and Innovation Act) is Section 708 regarding the handling and disposition of imported prescription medicines which, under the authorization of the Secretary of Health and Human Services (HHS), seized medicines determined to be counterfeit, bogus, misbranded or of potential harm to the health of American citizens, and determined to have a value of $2500 or less, may be destroyed by the agency making the seizure.
The rules promulgation process is nearing completion. After the rules are presented for review and comment, there will be a 60-day period for stakeholders, including TodaysSeniorsNetwork and RxforAmericanHealth.blogspot.com, acting with other advocates of personal importation on behalf of the more than one million Americans for whom personal importation provides a lifeline to vital drugs, to comment to urge rules that protect their continued access to these safe, affordable medicines.
We anticipate that we will be a part of a broad community of support, an indication of which is a petition that was recently launched by Dr. Stephen Barrett, a North Carolina physician who purchases his personal medications from an Internet Pharmacy.
Dr. Barrett’s Petition urges HHS Secretary Kathleen Sebelius to fully consider the potential harmful impact to the health of Americans by the unwarranted seizure and destruction of medicines that are safe and present no threat to Americans’ health.
We are heartened by Dr. Barrett’s concern about the potentially harmful outcome of the misapplication of any rules that might eventually emerge after stakeholders have the opportunity to be included In the development of the final rules and their implementation, and are pleased to preset the following information for your consideration and support.
The petition is located on http://www.change.org/petitions/kathleen-sebelius-please-don-t-stop-americans-from-getting-medicine-at-lower-cost-outside-the-u-s?utm_source=guides&utm_medium=email&utm_campaign=petition_created .