Archive for the 'Packaging & Labeling' Category

CMOs and the Track-and-Trace Race: Are You Engaged Yet?

Ian Haynes of 3C Integrity - Low ResFormer AstraZeneca engineer and serialization specialist, Ian Haynes, looks at the first practical step contract manufacturing organizations need to take to implement a compliance strategy ahead of the impending serialization deadline.

Increasing concerns are being expressed by industry observers and top-tier pharmaceutical manufacturers that contract manufacturing organizations (CMOs) will not be ready to comply with emerging track-and-trace requirements. Read more »

Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy, and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by FDA with labeling that links prescribing to specific biomarker measures, health plan operators, providers, and payers

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frequently question the need to cover the added testing, according to analysis by Joshua Cohen of the Tufts Center for the Study of Drug Development (CSDD). Cohn noted at a recent CBI conference on “Precision Medicine and Companion Diagnostics” that only a few therapies have been approved by FDA

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inform prescribing; several more drugs gain links to specific diagnostics post- approval.

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Senate Finalizes Drug Compounding, Tracking Legislation

Congress gave final approval this week to new legislation to strengthen FDA authority to oversee large pharmacy compounders of sterile injectables and to require more comprehensive tracking of prescription drugs moving through the global supply chain. The House passed the the Drug Quality and Security Act in late September, but Senate action was delayed, first by the federal government shut-down in October and then by individual efforts to force a vote related to Obamacare.

But continued public outrage over deaths from contaminated injectables produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the US market, managed to overcome the partisan stalemate on Capitol Hill to win strong approval for the measure. No one gets all they wanted from the legislation, but it provides more clarity and predictability to drug oversight programs and moves forward initiatives designed to enhance the safety and quality of medicines in the United States.

Alan Coukell, senior director of drugs and medical devices at The Pew Charitable Trusts, praised the bill as “meaningful” and said that efforts to block counterfeit and contaminated drugs will “help protect lives and alleviate these costs by ensuring that prescription drugs are safe, effective and of the highest quality.”  President Obama is expected to sign the bill fairly quickly

Voluntary system
As previously noted here, the first section of the bill clarifies FDA’s authority over drug compounding, which resolves questions raised by diverse federal court rulings on the issue. Pharmaceutical manufacturers gained legislative language specifying that compounders cannot produce drugs that are “essentially a copy of a marketed drug.” But the bill is not as strong as FDA and patient advocates had hoped, as it fails to set specific criteria to differentiate large commercial operations from local compounding pharmacies. The legislation instead relies on a voluntary registration system for large-scale compounders, which will have an impact only if large purchasers of compounded drugs insist that their suppliers meet FDA standards.

Pre-empting states
The main gain for manufacturers from the drug supply chain security section of the act is to pre-empt state pedigree laws, including the comprehensive California statute slated to go into effect in 2015. The new bill generally follows the Senate’s 10-year time-line for establishing an electronic, interoperable, unit-level drug tracking system. All drug packages will have to carry serial numbers in four years, and FDA will establish verification and traceability standards and provisions for data exchange.

The tracking system will include manufacturers, wholesaler/distributors and pharmacies, with some exceptions for small firms. In addition, third-party logistics providers such as Federal Express and UPS get a pass on keeping records and participating in investigations, which could create serious gaps in the tracking process.

Some critics blasted the bill for giving industry so much time to establish unit-level tracking and for imposing fairly weak oversight of compounders. But FDA, manufacturers, and policy makers seem pleased to gain enactment of any legislation at all. The long-term impact remains to be seen.

Liability Looms for Generic-Drug Safety Labeling Changes

FDA is proposing to revise its rules to permit generic-drug manufacturers to initiate safety-labeling changes instead of waiting until the brand company takes action. The aim of the new policy is to inform consumers more quickly of emerging safety concerns, but it also could create confusion by allowing prescribing information to differ among generic and brand products.

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Prepare for Serialization Now

Upcoming requirements in the US and around the world for serialization and track and trace of pharmaceuticals were a focus of the Pharmapack conference held in Philadelphia, PA earlier this week. Momentum toward implementing these technologies across packaging lines is building as deadlines, including California’s requirements in 2015 and others around the world, approach. After listening to several presentations and a panel discussion, the message I heard loud and clear was that time is of the essence and that packagers should prepare for serialization now. Read more »

Color-Changing Sealant Technology Enhances Package Security

Rollprint Packaging Products’ new, patent-pending, color-changing sealant technology is appropriately named Chameleon; it enhances product security with a color change indicating that a pouch or tray lid has been opened. Read more »

Odorous Taints Linked to Treated Wood Pallets

It is amazing what the human nose knows.  Well, those who originally detected a musty, moldy odor in pharmaceutical and healthcare products didn’t know where it came from.  But the odorous taints that resulted in product recalls were found to come from tribromoanisole (TBA) and trichloroanisole (TCA), and have been linked to treated wooden pallets from sources outside the US, the Parenteral Drug Association (PDA) reported in a September PharmTech article, which summarizes the findings of the recent PDA Technical Report No. 55 on detecting and mitigating taints and odors from TBA and TCA. Read more »

A Taste Of Someone Else’s Medicine

Stephanie Sutton Pharm Tech EuropeMistakes happen. In the pharma industry, these mistakes can lead to product recalls. Perhaps the medication is not the correct strength or maybe it became contaminated with metal fragments…

…and sometimes, entirely the wrong drug is found in the packet. In a case that has had UK media reports aflame, a prescription only antipsychotic drug was found in certain packets of a common pain medication that was manufactured by a completely different company. Is it a repackaging mistake? Or are more sinister intentions at work? Either way, it’s clear there are could be a few security holes in pharma’s distribution chains. Read more »

The Weight of the Matter: Revising Children’s OTC Labeling

Angie Drakulich PharmTech editorFDA may soon revise the labeling of over-the-counter pediatric medications to place a stronger emphasis on weight rather than age for dosing instructions. In mid-May, two advisory committees to the agency, the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee, recommended a change for children’s OTC medicines that contain acetaminophen, such as Tylenol. The labeling issue has been a concern for many years now, and has gained attention since January 2008, when postmarket adverse events were reported for McNeil Consumer Healthcare’s pediatric formulations of Tylenol, Motrin, Zyrtec, and Benadryl. Read more »

OTC Liquids and FDA Guidance

Angie Drakulich PharmTech editorThe subject of over-the-counter drugs is quite popular lately (see related blog post, “Using Drugs Right”), probably because of the many OTC drug recalls that have occurred in the past 18 months, and also because OTCs are part of most Americans’ daily lives (especially now, when the allergy season is running rampant across the US). FDA released this week a new final guidance, on OTC drug products, this one focusing on liquid medications that have dispensing devices.

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