The wait is over. In a recent announcement, the US FDA has asserted that the proposed rule of labeling pertaining to generic drugs will be released in July 2016. The much anticipated rule is expected to ensure that utmost importance would be given to the patient safety while securing the rights of generic drug manufacturers. Before mulling over how the proposed rule would affect the generic manufacturers’ dependency, let us try getting some facts about the patient safety and the labeling status-quo.

Influence of the Present Rule

As per the current regulations for updating the drug label, the guidelines are different for branded drug manufacturer and generic drug manufacturer that creates a timeline difference (which is generally more for generic drug manufacturers) for both manufacturers, to update and implement any safety related information on the packaging. Such a delay may cause health complications for a patient who is buying a generic drug whose safety information has not been updated on the package.

Corresponding to present guidelines, generic drug manufacturing companies cannot update product labels independently for any new safety information associated with new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs). This situation poses threat to patients’ health as companies cannot warn users about any safety issue identified, which is yet to be specified on the reference product’s label.

What would the New Rule Entail?

After final considerations, if this rule comes into force, generic drug manufacturers will be able to issue a labeling update related to any safety information change in short timelines. It will entail a process that would allow the discrepancies to exist on temporary basis among the brand name reference products, generic drugs and approved generic drugs. When companies are filing applications to FDA for labeling change, they need to provide relevant information that describes the basis for label change along with:

• New data to be implemented after the change
• Published literature
• Adverse event data
• Epidemiologic studies

FDA says

“The rule may encourage generic drug companies to participate more actively with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements.”

Whenever FDA proposes a new rule, apart from elaborated internal discussions, the agency also considers suggestions from public docket to create the final guideline. For this particular guideline associated with safety label updating process, FDA received approximately 2300 comments which will be taken into consideration together with the final financial implications and benefits.

Approach, Approvals and Beyond

Once the manufacturer has found some discrepancy or risk with the new drug, the need of the hour is to report the issue to the US FDA and get the approvals for necessary label changes. Following approvals, the manufacturer may update the safety in different ways:

• by submitting a New Drug Application (NDA); to reflect new indication for use
• a Prior Approval Supplement (PAS); to propose other substantial changes
• through Annual Reports; for minor changes regarding extension of expiry date
• by submitting Changes Being Effected (CBE-30 & CBE-0); for immediate moderate changes

In this scenario, generic drug manufacturers, on finding an issue, can notify the FDA by filing CBE – 0 to make immediate changes to the label information furnishing the below details.

• the basis of the labeling change
• data pertaining to adverse events and
• related studies

Though the CBE-0 differentiates the RLD and generic drug labels temporarily, regulatory mechanisms eventually will align both the labels as per the same standards.

The Pros & Cons

Maintaining the uniformity of the label as that of an RLD might seem advantageous for generic manufacturers:

• to accelerate approval processes
• to save much of the time without any need to get involved in the rigorous tracking of safety issues
• to safeguard themselves from failure to warn instances

However, with the fact that the proposed rule itself has some serious conflicts with that of the Hatch-Waxman act, the health authority has a long way in sorting out a legal deadlock to ensure the possibility of rolling out the mandate anytime, soon. Meanwhile, let us bring to you how this rule is going to affect both the end users and the generic drug manufacturers.

Disagreements Witnessed For the Rule

Lot of disagreements were unveiled in generic industry against the proposed rule, as some sponsors believed that new legal liabilities and delay in announcing the final rule would bring financial instability and lead to loss of billions of dollars to generic companies. They proposed that FDA should be quick in making final decisions intended for this rule and ensure that updated safety information is accessible by patients on time.

In Conclusion: A Challenge Ahead for GDMs

As generic drug industry awaits for the new rule to be released by FDA, manufacturers should get ready to have a quick response time in case of any change in safety information. This will be a challenging task, as presently the generic drug manufacturers are uninformed of the complete information about the final guideline.

The consumer healthcare industry is catching-up fast with the changing consumer behavior by delivering value driven product categories across consumer segments. Unlike before, where there was little data to support the strengths of claims, scientific studies, and justifications backs up the brands today. Growing awareness among consumers with the trend of digital and mobile platforms across the globe is playing a dual role. At one end, concerns about personal wellness and health are growing among the consumers, at the same time, exposing them to myriad choices of products, based on information freely available online and peer recommendations. A consumer can easily check the quality of product by connecting with peers in another part of the world who have had used it. In this industry, consumer is the king who drives the key buying decisions.

The industry is adapting to a value-driven portfolio compared to volume-based approach focusing on benefits over price premium capitalizing on consumers’ informed peer driven choices. This has put global players in a situation to meet fast emerging consumer needs while maintaining the quality in a continuously evolving global regulatory landscape. In such a rigorous environment, a single adverse event related to a product can significantly damage a brand’s image and its market. Organizations no longer are willing to risk a product without considerable clinical claims which not only ensure consumers’ trust with the brand, but also enable brands to place their products as the best health management solution.

Challenges in Developed and Emerging Markets

The market dynamics of consumer healthcare industry favors consumer goods companies like Unilever, Reckitt Benckiser and similar organizations who have strengthened their regulatory teams to align with the changing regulatory framework while banking on their vast experience with consumer driven market.

Pharma companies, being well versed with complex regulatory environment, find it challenging to drive the consumer health divisions since the guidelines that monitor the pharma products often reduce the speed at which consumer healthcare portfolio should operate.

Developed markets have transparent and streamlined regulatory processes; however, it may not be same in emerging markets. Especially when industry is trying to maximize its profits over its portfolio by venturing into new markets, the local regulations pose new challenges at multiple levels.

Most of the health authorities worldwide follow the EU legislations with some degree of variation; however, the specific variance, timeline for implementation of changes and modality mostly remain unknown.

Often manufacturers face challenges during the export when they discover that a new regulation can affect their current batch. The available regulations published online is a challenge to comply with, as they pose language barriers. This is a common pattern witnessed across markets like Africa, Latin America, Asia, and some European countries. In such scenarios building a comprehensive market strategy for all Asian countries, becomes a challenge compounded by limited availability of online information and complex on ground dynamics.

Cost

As the industry is facing new challenges in the evolving regulatory environment, cost continues to be a prominent hitch for the organizations. The fast-moving consumer health industry attracts diverse competition from niche market players like nutraceuticals, dietary supplements, and technology companies such as Google and Apple rolling out health management applications based on big data, resulting in increased cost pressure to maintain a healthy bottom line.

Recognized brands are striving towards capitalizing the price premium, based on brand loyalty, while other brands and products need equal resources and investment to sustain the operation margins. There is a need for striking a right balance across quality, benefits, and cost by implementing innovative, comprehensive, and intelligent models.

In Conclusion

Global organizations are moving towards centralization utilizing strategic inputs from stakeholders including industry thought leaders, global department leads, and local market experts, regulatory and operational experts translating them into holistic roadmap for managing product portfolios, go-to market strategies, licensing and innovations.

The dynamic environment of pharma regulatory for packaging & artwork has set forth huge challenges for the pharmaceutical and life sciences companies in terms of meeting the latest mandates. Subsequent to the rapid updates in artwork regulations, companies are facing one of the most crucial phases in their life cycles. Where, on the one hand the existing product chain is running out of patent timelines, leading to major financial challenges, on the other hand the traditional products are struggling to meet the regulatory compliance gaps due to regulatory changes. Moreover, the growing global markets are giving rise to expansion of new markets around the globe, posing a threat to the passive traditional markets.

To fix the situation incepted as a result of dynamic artwork regulatory challenges, companies are manifesting manufacturing more variations and alternatives to their current products and launch their products in the emerging markets. Implementing this practice leads to changes in the physical packaging of the products as the components change, thereby making the artwork creation and maintenance, an intricate process to achieve.

For companies with an extensive product line distributed around the globe indifferent regions, a perfect balance between business process and product information management is required, to keep up with Artwork compliance. However regardless of the size of the organization, companies witness similar errors/defects throughout the Artwork creation, few of which are discussed below:

Content Defects

This direct error is observed in the detailed Artwork information about the product. Errors like omissions or placing incorrect symbols in the information generally dive into this category.

Gross Defects

This major error arise because of an important piece of information missing completely from the detailed product information. Such an information can be a recent regulatory update that entails changes in the Artwork.

Technical Defects

The technical aspects of packaging line, such as the barcode on the pack, may lead to these errors because of the incorrect specifications or information about the product mentioned in the barcode.

Context Defects

This error implies that the information on the Artwork is mentioned in an abstruse or an incorrect way that may mislead the perspective of the information. Such errors may appear because of inappropriate use of symbols or special characters.

In Conclusion

These errors in packaging Artwork can bring about harsh implications for the companies in terms of revenue loss due to product recall if failed to meet the regulatory compliance or even put their reputation on risk in the global market. Regulatory experts around the globe recognize these risks and are dedicated to drive advanced operations that leads to error-free packaging artwork creation following the regulatory environment. It has been observed that lack of good communication and competence are few of the major reasons for these errors to appear. So it is needed for companies to rely on trained specialists that are well acquainted with the latest regulatory updates and are proficient in managing the pharmaceutical artwork creation lifecycle.

STRATEGIC RESOURCE ALLOCATION FOR CMC SERVICES TO A GLOBAL TOP 3 CONSUMER HEALTHCARE COMPANY

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24 CMC Variations (amendments) for established medicinal product for treatment of hemorrhoids and other related anorectal conditions in 12 African countries

CHALLENGES

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FREYR SOLUTIONS & SERVICES

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Freyr successfully prepared WID for seamless Process Standardization providing round-the-clock support to the CCDS update/development.

BENEFIT HIGHLIGHTS

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BUSINESS IMPERATIVES

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CHALLENGES

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FREYR SOLUTIONS & SERVICES

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CLIENT BENEFITS

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• This also helped in the seamless transition from old to new process

“Under the EMA’s tight timelines, your resource has successfully delivered on commitments with overwhelming speed and decisiveness ensuring we met the requirements on time. We just wanted to recognize their hard work and diligence on the product information update for a drug. Within just few weeks of their stint at our organization, they successfully navigated our processes and integrated them into the product team. Quite impressive! We must reiterate!”

Senior Regulatory Associate,
Worldwide Regulatory Strategy
A leading research-based global Biopharmaceutical Company

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A full-service Clinical Research Organization (CRO)
Based in Florida