Transparency practices at the FDA: A barrier to global health.

Data sharing among regulators must be "business as usual".

The case for an HIV cure and how to get there.

In light of the increasing global burden of new HIV infections, growing financial requirements, and shifting funding landscape, the global health community must accelerate the development and delivery of an HIV cure to complement existing prevention modalities. An effective curative intervention could prevent new infections, overcome the limitations of antiretroviral treatment, combat stigma and discrimination, and provide a sustainable financial solution for pandemic control. We propose steps to plan for an HIV cure now, including defining a target product profile and establishing the HIV Cure Africa Acceleration Partnership (HCAAP), a multidisciplinary public-private partnership that will catalyse and promote HIV cure research through diverse stakeholder engagement. HCAAP will convene stakeholders, including people living with HIV, at an early stage to accelerate the design, social acceptability, and rapid adoption of HIV-cure products.

Pandemic Best Regulatory Practices: An Urgent Need in the COVID-19 Pandemic.

As large numbers of candidate drugs and vaccines for potential use in the coronavirus disease 2019 (COVID-19) pandemic are being investigated, medicine regulators globally must now make urgent, informed, contextually risk-1based decisions regarding clinical trials and marketing authorizations. They must do this with the flexibility demanded by the pandemic while maintaining their core risk assessment and public safety functions. We lay out the critical role of regulators in the current crisis and offer eight "pandemic best regulatory practices." These should support both the regulatory public heath imperative and assure timely patient access to effective, safe, quality products worldwide during this emergency-thus contributing to ending this pandemic as quickly, effectively, and safely as possible.

Scientific considerations for global drug development.

Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.

The cost of entry: An analysis of pharmaceutical registration fees in low-, middle-, and high-income countries.

BACKGROUND: Advances in pharmaceuticals offer improved health outcomes for a wide range of illnesses, yet medicines are often inaccessible for many patients worldwide. One potential barrier to making medicines available to all is the cost of product registration, the fees for regulatory review and licensing for the sale of medicines beyond the cost of clinical trials, if needed. METHODS AND FINDINGS: We performed a cross-sectional analysis of pharmaceutical registration fees in low-, middle-, and high-income countries. We collected data on market authorization fees for new chemical entities and for generic drugs in 95 countries. We calculated measures of registration fee size relative to population, gross domestic product (GDP), and total health spending in each country. Each of the 95 countries had a fee for registering new chemical entities. On average, the ratio of registration fees to GDP was highest in Europe and North America and lowest in South and Central America. Across individual countries, the level of registration fees was positively correlated with GDP and total health spending, with relatively few outliers. DISCUSSION: We find that, generally speaking, the regulatory fees charged by medicines regulatory authorities are roughly proportional to the market size in their jurisdictions. The data therefore do not support the hypothesis that regulatory fees are a barrier to market entry in most countries.

Optimized Medical Product Regulation in Mexico: A Win-Win for Public and Economic Health.

BACKGROUND: Medicines regulators, while performing a vital public health activity, are often perceived as both negative cost centers for governments and as impediments to innovation and economic development. The Mexican government recently undertook a regulatory optimization program focused on transforming the Mexican medicines regulatory pathway into one that is efficient, value-added, aligned with international norms, resource accountable, and one that protects and promotes public health, while also facilitating economic development. METHODS: To facilitate the implementation of a new national access to medicines policy, the national government and the Mexican medicines regulatory agency instituted a multifaceted series of regulatory and legal reforms, which are described in this paper. These reforms encompassed multiple aspects of the regulatory oversight of medicines: administrative processes, clinical trials oversight, reliance on market authorization information and reports (ie, "work products") of other trusted regulators, and validation of activities by both Pan American Health Organization (PAHO) and WHO. FINDINGS: These reforms have resulted in a marked positive impact on the availability of safe, effective, quality medicines at lower costs for Mexicans, both in the private and public sectors, while simultaneously facilitating expansion of the Mexican pharmaceutical industry. INTERPRETATION: The regulatory optimization approach undertaken by Mexico could be a useful model for other countries that are trying to provide appropriate public health protection to their citizens, facilitate access to needed quality medicines, and encourage local economic development.

De la FDA (FOOD AND DRUG ADMINISTRATION) Estados Unidos: Informes sobre hematomas epidurales o espinales con el uso simultáneo de heparina de bajo peso molecular y anestesia espinal/epidural o punción espinal / From the FDA (FOOD AND DRUG ADMINISTRATION) USA: Reports about epidural or spinal hematomas with the simultaneous use of heparin of low molecular weight and spinal/epidural anesthesia or spinal punction

Hasta el mes de noviembre de 1997 se recibieron más de 30 informes voluntarios describiendo pacientes que desarrollaron hematomas epidurales o espinales con el uso simultáneo de enoxaparina sódica y anestesia espinal/epidural o punción dural. La mayoría de los hematomas epidurales o espinales causaron lesión neurológica, incluyendo parálisis prolongada o permanente. Apróximadamente el 75 por ciento de los pacientes fueron mujeres de edad avanzada que se sometieron a cirugía ortopédica. En este momento la FDA considera que los médicos deben tener presentes las siguientes consideraciones si utilizan estos productos: Cuando se emplea anestesia neuraxial (anestesia epidural/espinal) o punción espinal, los pacientes tratados o que van a ser tratados con anticoagulantes del tipo heparina de bajo peso molecular o heparoinoides para prevenir complicaciones tromboembólicas, tienen riesgo de desarrollar hematoma epidural o espinal que puede producir parálisis prolongada o permanente. El riesgo de estos episodios se incrementa con el uso de catéteres epidurales continuos para administrar analgesia o por el uso concomitante de drogas que afectan la hemostasis como las drogas antiinflamatorias no esteroides (DAINES), los inhibidores de las plaquetas u otros anticoagulantes. El riesgo también parece incrementarse con la punción espinal o epidural traumática o repetida. Se debe monitorear con frecuencia a los pacientes por signos y síntomas de deficiencia neurológica. Si se observa compromiso neurológico, es necesario un tratamiento urgente. Los médicos deben considerar en su totalidad el beneficio potencial versus el riesgo antes de la intervención neuraxial en los pacientes que recibieron o recibirán anticoagulantes para la tromboprofilaxis. (AU)

De la FDA (FOOD AND DRUG ADMINISTRATION) Estados Unidos: Informes sobre hematomas epidurales o espinales con el uso simultáneo de heparina de bajo peso molecular y anestesia espinal/epidural o punción espinal / From the FDA (FOOD AND DRUG ADMINISTRATION) USA: Reports about epidural or spinal hematomas with the simultaneous use of heparin of low molecular weight and spinal/epidural anesthesia or spinal punction

Hasta el mes de noviembre de 1997 se recibieron más de 30 informes voluntarios describiendo pacientes que desarrollaron hematomas epidurales o espinales con el uso simultáneo de enoxaparina sódica y anestesia espinal/epidural o punción dural. La mayoría de los hematomas epidurales o espinales causaron lesión neurológica, incluyendo parálisis prolongada o permanente. Apróximadamente el 75 por ciento de los pacientes fueron mujeres de edad avanzada que se sometieron a cirugía ortopédica. En este momento la FDA considera que los médicos deben tener presentes las siguientes consideraciones si utilizan estos productos: Cuando se emplea anestesia neuraxial (anestesia epidural/espinal) o punción espinal, los pacientes tratados o que van a ser tratados con anticoagulantes del tipo heparina de bajo peso molecular o heparoinoides para prevenir complicaciones tromboembólicas, tienen riesgo de desarrollar hematoma epidural o espinal que puede producir parálisis prolongada o permanente. El riesgo de estos episodios se incrementa con el uso de catéteres epidurales continuos para administrar analgesia o por el uso concomitante de drogas que afectan la hemostasis como las drogas antiinflamatorias no esteroides (DAINES), los inhibidores de las plaquetas u otros anticoagulantes. El riesgo también parece incrementarse con la punción espinal o epidural traumática o repetida. Se debe monitorear con frecuencia a los pacientes por signos y síntomas de deficiencia neurológica. Si se observa compromiso neurológico, es necesario un tratamiento urgente. Los médicos deben considerar en su totalidad el beneficio potencial versus el riesgo antes de la intervención neuraxial en los pacientes que recibieron o recibirán anticoagulantes para la tromboprofilaxis.