Puerto Rico

Increasing the capacity for local development and production of medicines and other health technologies in Latin America and the Caribbean is among the objectives of the new deal.

Of GMP warnings for OTC hand sanitizers, 114 have been submitted by FDA since pandemic began, with first sent in late April 2020, and another 12 for false COVID-19 claims, with first sent on 1 April. One GMP warning for hand sanitizer product is listed in both 2018 and 2019.

In the wake of signing a drug transfer and development agreement with Biosimilar Solutions in the firms’ native Puerto Rico, OcyonBio’s CEO Robert Salcedo spoke with Generics Bulletin about the company’s ambitions to put the US territory on the map for biosimilars.

Tuberculosis or cancer, sterility assurance or shortages, the choices come at you fast; Takeda, Wintac, Banco Vida updates.

Until FDA on 23 June posted report about Golden Nutrition Inc.’s herbal supplement, violative COVID-19 claims had been found online and in advertising through other channels. Other consumer health recalls in US include more than 2.5m bottles of Gaviscon Liquid Antacid missing a safety warning on labels.

UK pharma announced that in 2021 it will close its manufacturing facility in Carlisle, PA, where around 260 people are employed making the Emergen-C line. It will move the manufacturing to its Guayama, PR, facility.

The need to screen individuals in dengue-endemic areas for prior infection before administering Sanofi’s vaccine will be difficult to operationalize, particularly in the absence of a reliable and rapid diagnostic, experts say; Advisory Committee on Immunization Practices working group aims for full committee vote on use recommendations in February 2020.

FDA recently sampled and tested targeted supplement products in a follow-up inspection to a Life Rising recall linked to lead contamination in 2017. Latest updates to FDA recalls database includes nearly 5.8m pounds of antibacterial or antiseptic hand washes that Inopak Ltd. produced in a facility found to be outside good manufacturing practices regulations.

Pfizer Consumer Healthcare division recalls one lot of ThermaCare Back Pain Therapy HeatWraps, up to 16HR pain relief, because the products could include cells that have a higher cell temperature than specified. Firm in late 2018 recalled six lots of ThermaCare HeatWraps Muscle Joint Therapy 8-hour strength due to reports of leaking heat cells.

The September hurricane destroyed Puerto Rican medical device plants, causing a shortage of several key products that's still being felt. FDA Commissioner Scott Gottlieb said Monday that the agency is allowing more imports and considering other tactics to ease the shortage.

Under tax reform legislation recently passed by Congress, a 20% tax on products made in domestic territories will adversely affect the many device firms with Puerto Rican plants that currently enjoy a lower, 4% tax rate on profits. And a second tax provision usually relied upon by medtech companies, the R&D tax credit, also loses ground under the final Senate bill passed Dec. 2.

Recovery from the hurricane, which devastated four Medtronic facilities located on Puerto Rico, is projected to cost $50m to $60m, according to a preliminary second-quarter earnings estimate from the firm. Last month, the company suggested costs could be as high as $250m.

Lantheus Holdings, Becton Dickinson are among manufacturers to say in recent financial reports that the hurricane has ongoing impacts for the companies.

The agency published warnings to four firms marketing supplements containing CDB ingredients with claims to treat or cure cancer made in statements including testimonials on their websites for products varying from oils, capsules, tinctures and lotions to snacks including gummies and lollipops.

While several device companies said they expected only minimal financial impact from the destruction of Hurricane Maria in Puerto Rico (as well as from Hurricanes Harvey and Irma in Texas and Florida) some firms, including Baxter and Integra, anticipate losses of tens of millions of dollars, according to Q3 earnings reports.

Medical-product manufacturers in Puerto Rico took a major hit from Hurricane Maria, but some are slowly getting back up to speed as portions of the island's electrical grid go back online and additional generator power is deployed by device and drug companies, FDA Commissioner Scott Gottlieb told a US congressional panel Tuesday. But he warned that some facilities are "'sole-source" providers of devices and drugs, and that some longer-term government support may be needed to prevent future product losses.

Continuing recovery efforts in Puerto Rico have US FDA focused on life-sustaining devices or those only made on the island. Meanwhile, manufacturers including Baxter, Zimmer, J&J and Abbott report varying impacts from the storms.

FDA commissioner underscores importance of restoring full production in Puerto Rico, where nearly 10% of all pharmaceuticals consumed in the US are made. Some plants have partially resumed operations under generator power, he notes, but the full recovery that at some point will be needed to prevent shortages will require restoring the island's power grid.

FDA has identified more than 40 high-priority drug products from at least five companies and is offering assistance to resume operations, including 'coordinating transport of certain critical drugs out of Puerto Rico.'

Pharmaceutical companies race to prepare manufacturing facilities in Puerto Rico, many of which date back to the 1980s and 1990s, for the arrival of Hurricane Maria.