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Track-and-Trace Not Enough to Halt Drug Counterfeiters

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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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.

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Drug Shortages Continue to Plague Healthcare System

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The Centers for Disease Controls and Prevention (CDC) similarly benefits from a budget increase of about 8 percent. CDC gains added funds to support biodefense programs that combat infectious disease and build national stockpiles of critical medicines.

But the National Institutes of Health (NIH) continues to suffer on the funding front. Congress set the NIH budget at nearly $30 billion, an increase of about $1 billion over its previous level. But the new amount is below the agency’s peak 2010 funding level that exceeded $31 billion. The

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Under pressure to stop the funding logjam, Republicans stepped back from using the budget bill to take major whacks at Obamacare. The legislators pulled $1 billion from a new prevention fund established by the Affordable Care Act to support various health programs,

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Waxman retirement, tip of the iceberg

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The Senate faces even more substantial changes, with the departure of leading Democrats Max Baucus of Montana, who currently

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PDA Panel Proposes Limited Set of Metrics to Measure Quality Trends

If FDA is going to establish standards for assessing the quality of manufacturing sites and products, it should seek data on a few well-defined measures that reflect longer-term results and trends, rather than “snapshots of current numbers.” And such metrics should include more leading—vs. lagging—indicators to reflect a firm’s commitment to continuous improvement in production processes. Those recommendations come from a PDA “points to consider” paper, written to help FDA set standards to measure product quality and manufacturing capabilities.

Read more »

Innovation on the Rise among Indian Pharmaceutical Companies

India has a name when it comes to generic drug development. According to a recent research on patent applications carried out by Withers & Rogers, innovation by Indian pharmaceutical companies has increased over the past few years; however, the quality did not match the standard seen in Europe. Read more »

FDA Expands Oversight of Large Compounders

Moving fast to bolster its authority over compounding pharmacies that operate as manufacturers of prescription drugs, FDA is urging “outsourcers” to register, seeking state support, and moving to issue more rules and guidance. The agency is pleased that 14 outsourcers registered through mid-January. The number is small, considering that an estimated 3000 compounding pharmacies make sterile injectible drugs, but this initial activity reflects FDA’s fast action in implementing the Drug Quality and Security Act (DQSA), which was enacted less than three months ago.

Read more »

Conference Programs Highlight InformEx 2014

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However, InformEx 2014, scheduled for Jan. 21-24 in Miami Beach, Fla., also features more mainstream conference topics. Conference programs are scheduled for Jan. 22-23 and will be located on the show floor. Exhibits are open Jan. 21-24.

The scheduled topics include an analysis of the current state of the pharmaceutical industry, where growth may come from, what new molecules may look like, and services drug manufacturers may require.

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studies, challenges encountered in formulation development and manufacture of clinical trial material when moving from Phase 1 to Phase 2 and 3 studies. Participants can also learn how pharmaceutical companies and CDMOs are aligning sustainability policies and how these programs can generate a significant return on investment.

Other sessions will address vulnerabilities in the chemical supply chain, intellectual property protection, recent advances in chemical technologies for the synthesis of glyochemicals and glycoconjugates, creating value in partnerships between pharma and technology providers, and market opportunities in personalized medicine for the fine, custom and specialty chemicals industry.

On Tuesday, Jan. 21, a full day of exhibitor technology showcases are scheduled.

Networking breakfasts, as well as the InformEx 30th Edition Celebration, provide opportunities for interaction.

More than 3,500 attendees from top pharmaceutical, fine chemical and specialty chemical companies — along with 450 exhibitors — will take part in InformEx 2014, organizers report.

If you are in attendance, please visit Pharmaceutical Technology at booth 1321.

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