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Industry keen on scientific considerations in paediatric drug development

Nandita Vijay, Bengaluru
Tuesday, May 30, 2023, 08:00 Hrs  [IST]

Pharma industry and the medical fraternity specifically the pediatricians understand the importance of the paediatric drug development. The latest US FDA guidance for the industry titled as Paediatric Drug Development under the Paediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations has considerable information to be adhered for safeguarding the paediatric patient population.

This is because many diseases that occur in adults also occur in children. The paediatrics are often treated with the same drugs as adults. The effects of many drugs may vary considerably for adults and children or for different paediatric subgroups.

Here pharma companies note that the new guidance is much desired and going by the dedicated basket of formulations researched and developed for the paediatric population. They see a need for regulations in manufacturing drugs for children. This is where the industry is keen on the scientific considerations for paediatric drug development.

According to a section of paediatrics, even though paediatric drug development does not differ greatly from the principles that apply to drugs developed for adults, yet this segment of the population is delicate in structure. Therefore as US FDA states that before initiating a development program in paediatric populations, the pharma industry applicants should consider the conditions to be investigated of the drug under study. This will go a long way to safeguard the health of the paediatric subpopulations for whom such a drug would represent a meaningful therapeutic option.
The purpose of this guidance is to assist industry in developing data and obtaining information needed to support approval of drug products in paediatric populations. This guidance addresses selected clinical, scientific, and ethical issues regarding the development of drugs for paediatric use when such drugs are subject to the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). In 2010, the Biologics Price Competition and Innovation Act of 2009 extended provisions of the BPCA to biological products, said the global regulatory authority.

Labelling for many drugs lacks information on the safe and effective use in all or certain paediatric age groups. Undeniably, labelling for many of the drugs that are widely used in paediatric patients specify that safety and effectiveness in paediatric patients have not been established. 

The absence of adequate paediatric use information in labelling poses significant risks for children. Inadequate paediatric dosing information in labelling may lead to inappropriate dosing that can increase the risk of adverse reactions and lead to ineffective treatments.

The lack of paediatric safety data may lead to inappropriate use in paediatric patients and expose such patients to the potential risk of age-specific adverse reactions that are unexpected based on data gathered from the use of the drug in adults.

The absence of adequate paediatric labelling also may deny paediatric patients therapeutic advances because physicians choose to prescribe drugs that are potentially less effective in paediatric populations due to the lack of information regarding use. Failure to develop an age-appropriate paediatric formulation of a drug may also deny paediatric patients access to important new therapies. It may result in paediatric patients taking formulations where bioavailability may be poor or inconsistent.

Hence US FDA brought in a Paediatric Review Committee (PeRC). It is here the Paediatric Research Equity Act requires that any applications falling within the requirements for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration must either include a paediatric assessment reports.


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