WASHINGTON — The Trump administration on Monday confirmed that it has agreed to pay $5.2 billion to US pharmaceutical company Pfizer to help the company meet an inventory agreement.
For nearly a decade, the Washington-based global drugmaker had operated under an agreement to ensure that it had enough of the pill to be used by people living with HIV for the next five years. The money would be used to buy the pharmaceuticals for those in high-risk populations, according to the Office of Management and Budget, which oversees the U.S. foreign assistance budget.
Pfizer’s purchases would cover pharmaceuticals that would be distributed in areas of the world that have high infection rates of HIV, such as parts of Africa, South America and the Caribbean.
Over the past few years, Pfizer has faced increasing scrutiny over its HIV drug portfolio. In 2017, the company agreed to an $850 million settlement with 43 states and the District of Columbia to resolve allegations that the company violated the federal False Claims Act. The allegations were related to its drugs Dolutegravir and Zyvox, which are sold under the names Viread and Trizivir and were associated with the development of resistance to HIV medications.
The company has also faced accusations of kickbacks to physicians. In a complaint filed in December 2016, attorneys general from 18 states and the District of Columbia alleged that Pfizer conducted a secret commercial program to pay HIV clinicians for referring patients to the company’s HIV medications.
Jeff M. Jonas, a Pfizer spokesman, said in a statement that the company has dealt with a surge in worldwide HIV incidence among people who do not have HIV or who have been cured of the disease, making it difficult to meet the demand for its products. He said the company has partnered with the OMB to help ensure it has enough drugs to meet the demand.
“The settlement serves the dual purpose of addressing an urgent global public health issue, while also addressing the company’s current ability to deliver the medications that serve as the cornerstone of HIV medication treatment in over 1 billion people,” Jonas said.
A report from the OMB in December 2017 stated that the company had made enough of the drugs “for approximately 10 million people for at least one month.”
OMB approved of the agreement the same month. The document did not specify how many people the agreement would cover. Pfizer did not give an exact number of people that would be covered by the program.
“At Pfizer, we work together with national and international health authorities to ensure that the medicine required is available to patients when and where they need it,” Jonas said.
He said the company has processes in place to ensure that medicines that would be provided under the agreement could be used by recipients within one month.
Most HIV medications are now derived from plant sources. These ingredients are sometimes found in tropical plants or rice husks, and others in rocks or bamboo, according to the National Library of Medicine.
The agreement is the largest transaction to date in the United States for the purchase of pharmaceuticals in the emergency prevention program, which the U.S. government began using in 2004 after international health experts advised the president that, in order to achieve a long-term decrease in HIV transmission, “the United States would need to produce an adequate supply of critical antiretroviral medications to prevent epidemic opportunistic infections in high-risk individuals, including new HIV infections among injection drug users.”
The agreement also involves the OMB’s Office of Procurement Services, which will provide financial support for the healthcare companies to buy the pharmaceuticals.
The agreement is one of the largest since the program’s inception, according to Susan Abramovich, a director at the OMB’s Office of Foreign Assistance Policy.