Partnership for Safe Medicines (PSM): a letter to President Barack Obama
Mr. President,
Please Alliance for Drug Safety (PSM), a group of organizations and individuals that have policies, procedures or programs to protect consumers against counterfeit drugs or contraband and security drug supply and safety of drugs, I praise her efforts to improve and expand health care coverage for millions significantly Americans who do not. However, PSM is deeply concerned that the race more vulnerable the higher risk of encountering counterfeit, adulterated or dangerous drugs and believe that a comprehensive approach is needed to solve the problem of patient safety.
We believe that security must be our national priority in any effort health reform. However, in regard to prescription drugs, today's Americans, unknowingly, the death or serious injury risks to their health by taking medications forged. Counterfeiting of medicines impact virtually all countries worldwide (115 in 2008) and almost all disease states. In fact, in 2008, there at least 651 different types of counterfeit brand name and generic prescription drug discovery. In recent years, with the best appearance and packaging, these criminals have made their products more difficult to forge detect.1 is clearly a problem of increasing globalization and requires many new types of international collaboration effective investigation and interdiction.
Issue: Import
Furthermore, this issue Drug Safety also has an interest particularly in the debate about importing prescription drugs to U.S. one of several projects planned cost reduction measures by Congress. I applaud your decision administration to study the issue before and I would ask that any analysis focuses on several areas including:
1. The lack of regulation for the products pass through safe countries like Canada and the advocates of drug importation in the UK believe drugs purchased in countries like Canada and the UK are safe due to their stringent sanitary standards. Unfortunately, this is simply not true. For example, Health Canada clearly drugs not affected by Canadians are not subject to safety standards of the Canadian government. Therefore, drug exporters can circumvent safety standards of Canada and the false mail or poor quality drugs manufactured in high-risk countries like China and India on Americans without the supervision of Health Canada.
2. Inability imported to meet U.S. demand and other supplier countries and the resistance of the citizens. There are simply not enough drugs in the supply chain to meet U.S. foreign legitimate demand. For example, if only half of older Americans changed their purchases from Canadian sources, it would deplete the supply drugs across Canada a few months. Therefore, providers and Canadians are opposed to the United States import.
3. Inaccurate perception security risk buying abroad. A policy of importing drugs give a wrong indication U.S. and even dangerous, the perception that drugs purchase at any pharmacy in the "Canadian" is safe because "the government allows the importation of drugs." This is particularly true for patients to purchase drugs at high risk for drug dealers over the Internet.
4. U.S. Politics in the hands of foreign governments. Congressional proposals would make our policy of import drugs into the hands of foreign governments. Price, quality, control (or lack thereof), and other key issues governments will be defined by another without worrying about protecting American patients with high potential for clear safety standards or enforcement. Also reduce chain security weak link in global supply.
5. Virtually no cost reduction. Congressional Budget Office estimated 2004 in his brief drug issue that the reduction in import prices of imported drugs would be "small" or "import some 1% … [Y] that allows only a negligible reduction in Canada would result in drug expenditure [. "All the savings would be negligible, as intermediaries reap all the benefits and leave little or no savings for consumers. The reality is that prescription drugs from a string of safety, reliable supply drug, regardless matter whether or not to allow importation of drugs will always be more expensive than an unsecured supply chain, potentially fraudulent.
Draft policy
Given these risks, we ask you to report to Congress on the need to ensure drug safety prescription. This affects us all, but our most vulnerable patient population, including minorities, elderly people and receive full debt effect of any failure of the policy. Instead, we must focus on creating access fund programs and maintain safe use is strictly regulated and inspected supply chain by the United States. This could include:
1. Offshore Support FDA and the Authority. The FDA needs funding and authority to develop programs and systems that extend to the drug supply chain.
2. Ground Support FDA / Agency and the Authority. The United States currently has 300 ports customs entry, but the FDA has only 200 inspectors of the port and only 17 inspectors to cover all international mail centers. We have to hire more inspectors between now and the granting of FDA and other agencies the power to destroy unapproved and counterfeit drugs entering the United States rather than return them to the criminal who sent them here, our current policy.
3. Illicit Internet Regulation seller. The Internet is a key security vulnerability in the chain supply of the United States. The Ministry of Health and Social Services should have the power to regulate online retailers on the merits, and legislation Federal should consider developing a drug dealer's Internet national certification program with the banking laws to limit suspicious transactions sales illegal drugs.
We believe that the actions of his administration to combat drug counterfeiting is known throughout the world. African and other have led the fight for the World Health Organization to raise the importance of this issue, and a clear signal of support for U.S. redouble their efforts and our relationships with them. Take steps to strengthen the authority of the FDA and the fight against drug traffickers over the Internet could be considered as a world of good practices and provide useful guidance to countries seeking to America for leadership. We are ready to assist in the development of legislation to achieve these policy objectives or to serve as a resource for you in matters relating to safe medicines. With very best wishes,
Marv Shepherd, Ph.D.
President, Association for Drug Safety
Bryan A. Liang, MD, Ph.D., JD
VP Partnership for Drug Safety
T. Thomas Kubic
Treasurer, Partnership for Drug Safety
Additional information is available by the drug safety this new website.
About the Author
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines and dedicated to medication safety and drug safety news.
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