House panel OKs ‘medicine stockpiling’ bill

calendar: House panel OKs ‘medicine stockpiling’ bill

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House panel OKs ‘medicine stockpiling’ bill

MANILA, Philippines — A House panel yesterday approved a bill seeking the stockpiling of medicines for public health emergencies like the current coronavirus pandemic.

The committee on health chaired by Quezon Rep. Helen Tan has approved the substitute to the proposed “Health Procurement and Stockpiling Act,” which seeks to ensure supply of critical drugs, vaccines, devices and materials in times of public health emergencies.

“The COVID-19 pandemic has shown the need to preposition critical and strategic pharmaceuticals and medical devices as well as the supply of raw materials. The country needs to be proactive in its response to public health emergencies,” explained Tan, principal author of the bill.

The bill proposes the creation of the Health Procurement and Stockpiling Bureau under the Department of Health, which will absorb the existing Procurement Service and the Supply Chain Management Service and serve as the principal agency mandated to undertake a transparent, fair, proactive and innovative procurement service for the DOH.

The new bureau will be tasked to stockpile, conserve and facilitate the release of adequate amounts of potentially lifesaving pharmaceuticals, vaccines, devices and materials in times of public health emergencies.

It will also be mandated to identify strategic and critical drugs and medicines, vaccines, devices and materials needed for public health emergencies that have the distinct capability of being stockpiled in strategic and secure areas of the country; supplement drugs and medicines, vaccines, devices and materials to state supplies acting as a stopgap buffer when the immediate supply of adequate amounts of drugs and medicines, vaccines, devices and materials may not be immediately available; and ensure the rotation, replenishment and freshness of stocks and that there exists at all times steady, available and adequate supplies in responding to public health emergencies.

The proposed DOH bureau will also lead in facilitating the creation of a conducive environment to encourage pharmaceutical and device self-sufficiency for medical supplies needed by the country and spearhead the crafting of a multi-sector National Drug and Device Security Program geared towards the country’s self-reliance in producing drugs and medicines, vaccines, devices and materials.

Tan pointed out that based on the Joint External Evaluation Mission report, the Philippines, due to its location, is one of the most natural-disaster prone countries in the world and in the past decade the country has faced challenges in making solid progress in infectious disease control.

“Given this situation, the country’s preparedness in times of public health emergencies is significantly necessary such as during pandemics and natural disasters,” the lawmaker stressed.?

In proposing the measure, Tan lamented how COVID-19 caught the country and the world flatfooted as it affected the global and local production and distribution of pharmaceuticals and medical devices as well as the supply of raw materials.

She recalled how some countries even imposed limits on export of medicines and medical supplies/equipment such as face masks, shields and ventilators to mitigate critical shortages in their countries likewise aggravated the situation.

The lawmaker cited, for

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EMA OKs First CAR T-Cell Therapy for Mantle Cell Lymphoma

The European Medicines Agency (EMA) today recommended granting conditional marketing authorization to brexucabtagene autoleucel (Tecartus), making it the first approved chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) in the European Union.

Brexucabtagene autoleucel is the third CAR T-cell therapy to be recommended for approval in Europe, but the only one for this indication.

The agent was approved for the same use in the United States earlier this year and was described by one expert as representing a “new frontier” in the treatment of MCL.

The new agent addresses an unmet need in MCL for patients who relapse or progress despite available therapies.

The current standard of care for this cancer includes stem cell transplantation and various therapy regimens, including Bruton’s tyrosine kinase (BTK) inhibitors, all of which are often initially effective. However, patients commonly relapse or stop responding to treatment, according to the EMA.

“This opinion is an important milestone for patients in Europe living with relapsed or refractory mantle cell lymphoma,” said Ken Takeshita, MD, global head of clinical development at Kite, the agent’s manufacturer, in a press statement.

It is based on safety and efficacy results from the multicenter, single-arm ZUMA-2 trial in 74 adult patients with refractory or relapsed MCL who had received at least two prior therapies.

During the study’s 12-month follow-up period, 84% of patients had a partial response and 59% had a complete response.

The most common side effects are cytokine release syndrome, infections, and encephalopathy. Monitoring and mitigation strategies for these side effects are described in the product information and the agent’s risk management plan.

Further efficacy and safety data are being collected as part of long-term follow-up from the pivotal study and an additional registry-based study.

Brexucabtagene autoleucel was supported through EMA’s Priority Medicines (PRIME) initiative, which provides early and enhanced scientific and regulatory support to medicines that have the potential to address unmet needs.

Nick Mulcahy is an award-winning senior journalist for Medscape. He previously freelanced for HealthDay and MedPageToday, and had bylines in, MSNBC, and Yahoo. Reach him by email and follow him on Twitter.

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