The Rx360 pharmaceutical supply chain consortium celebrated its first five years with an anniversary conference the week of June 5, 2014 in Washington, D.C. The conference featured key FDA officials and industry leaders. This collaborative effort to streamline and coordinate manufacturer audits of ingredient suppliers was launched in 2009 in response to the heparin adulteration crisis, which raised broad concerns about inadequate monitoring of the pharmaceutical supply chain by manufacturers.
Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight. Criminals are expanding from “lifestyle” drugs to widely used anti-cholesterol and cancer medicines, attracted by huge profits and low risks from drug counterfeiting activities, noted Marcia Crosse, director
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for healthcare at the Government Accountability Office, testifying at a Feb. 27, 2014 hearing before the House Energy and Commerce, Oversight and Investigations subcommittee.
A main problem is that penalties for distributing counterfeit drugs are too low to spur prosecution and to deter illegal operators, explained Howard Sklamberg, FDA deputy commissioner for global regulatory operations and policy. FDA is working with other federal agencies to identify and take action against illegal operators, with a focus on fraudulent Internet pharmacy sites that sell low-cost “Canadian” medicines. But most counterfeiters end up facing charges of “misbranding” or importing “unapproved foreign-made drugs,” which carry minor fines and minimal jail terms.
Health plans that limit drug converge may encourage consumers to obtain medicines illegally, according to pharmacy experts. Marv Shepherd, director of the Center for Pharmacoeconomic Studies at the University of Texas College of Pharmacy and others noted at the Partnership for Safe Medicines Interchange in October in Washington that an increase in narrow health plan formularies that carry only one or two drugs per class or category will boost purchases of substandard, counterfeit and diverted prescription medicines through illicit operators. Patients accustomed to treatment with a certain drug may seek out other sources of supply if a streamlined plan fails to provide coverage for that medicine, explained Bryan Liang, anesthesiologist and law professor at the University of California San Diego.
In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin. In response to the 2008 heparin situation, the United States Pharmacopeia Convention (USP) has revised the quality standards for heparin. Anita Szajek, PhD, and Tina Morris of USP highlight USP’s revisions to the heparin sodium monograph in the September 2012 issue of PharmTech.
With around 80% of APIs manufactured outside the US, many in developing nations without strong regulatory oversight, ensuring the quality and safety of the US’s drug supply is a herculean task. FDA has already taken steps to increase the number of overseas inspections, but it is impractical to assume that one agency is capable of inspecting the world’s manufacturing operations on its own. The Institute of Medicine released a report on Apr. 4, 2012 outlining several practical steps that FDA could take to strengthen supply-chain security. Read more »
Last week, counterfeits of the anti-cancer drug Avastin were discovered in the US and this week fake pharmaceuticals continue to occupy headlines. Read more »
Drug shortages are increasing at an alarming rate. Between 2005 and 2010, the number of drug shortages per year leapt from 61 to 178. This year’s total, 220 as of October, already surpasses that of last year. Fortunately, FDA has taken a step that is intended to prevent drug shortages from becoming crises. Read more »
Another very busy day at CPhI Worldwide and co-located events with good meetings in every corner for all exhibitors.
If you missed yesterday’s blog, the winner of the Innovation Awards was Glycotope for its GlycoExpress platform technology, which optimised glycosylation of antibodies and other biotherapeutics. The award was received by a very proud and happy Jens Pohl, managing director on Oct. 25, 2011. Read more »
This week, vaccine manufacturers won increased protection from liability in a closely watched case before the US Supreme Court. In Bruesewitz v. Wyeth, the Court ruled that federal law prohibits patients who claim to have been injured by a vaccine from suing the manufacturer. Pfizer hailed the decision as a victory for public health, but its effect is to diminish patients’ recourse when they suffer harm from taking faulty products. Read more »
Industry executives revealed their biggest worries for global supply-chain management in a report by PricewaterhouseCoopers and the analyst firm Axendia that focused on major areas of concern in the pharmaceutical supply chain. The report, titled Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences: Business Imperative, Regulatory Necessity, surveyed 112 executives from the pharmaceutical, medical device, and biotechnology sectors. Read more »