Mrs Carmona hits drug import delays

Speaking at the Hospice’s tea party on Sunday at the Hyatt Regency, Carmona said, “there is a particular medication that we, as part of the Vitas House Hospice family, have requested permission from the designated authorities to ease the physical plight of the terminally ill at Vitas House, and for years nothing is forthcoming.” The drug, she said, has already been approved by the United States Food and Drug Agency (FDA) for many years.

The harsh truth, she said, “is that approval for the use of new drugs is not being addressed with the required speed and sense of urgency.” Many in the region who require drugs like oxycodone, opioid analgesics, she said, cannot source them and sometimes die painful deaths.

Noting that FDA approved drugs for the terminally ill and other patients take a long time to be approved, Carmona said, “We are often burdened by onerous regulations that are systemic and systematic with indifference, institutional apathy and not enough forward thinking and a perceived lack of care.” The FDA represents international benchmark standards for the operationalisation and use of new drugs, she said and suggested that Trinidad and Tobago and other Caribbean nations which lack funds, infrastructure and human resources, approve drugs for the terminally ill and other patients based on FDA standards.

“The average waiting time for approval, I have been informed by stakeholders,” she said, “is over two years.” Sometimes by that time, she said, the life span of samples have expired and new ones must be resubmitted. The delay is not just about time management or marketing strategies or even skewed bureaucracy, she said, but about people’s lives, the terminally ill, family members and friends.

“Having spoken to other stakeholders,” she said, “the non-approval of new drugs is further burdened by an environment that makes no comprehensive, informed provision for the execution of clinical trials involving new and experimental drugs.” Currently boxes of drugs and dossiers are waiting to be approved at the food and drugs division, she said.

The food and drugs division, like others in the region, she said, “is simply overwhelmed through lack of resources, weak infrastructure and insufficient personnel, to fully and competently carry out its mandate.” She suggested that in the same way the Bahamas enacted legislation to import pharmaceuticals following prescribed international standards set by international pharmacopeia like the US and the the Europeans, that TT adopt similar legislation.

This not only saves time, but also money, she said, as the authorities would save on paying experts to approve the many dossiers submitted to them.