Americans for Safe Drugs: Congress Must Hold FDA Commissioner Califf Accountable for Shortages

WASHINGTON — Americans for Safe Drugs today released a list of questions that Members of Congress should ask Food and Drug Administration (FDA) Commissioner Robert M. Califf, M.D. this week. Commission Califf is appearing before the House Energy and Commerce Committee in a hearing tomorrow and the Senate Health, Education, Labor, and Pensions Committee in a hearing on Thursday. The questions focus on the FDA’s lack of action on addressing shortages of essential and lifesaving products, including critical generic medicines and baby formula, and the agency’s failure to help increase domestic production. Additionally, Americans for Safe Drugs is urging members of the committee to question Commissioner Califf on why the FDA continues to allow foreign manufacturers in China and India that repeatedly violate FDA regulations to continue to export generic medicines to the U.S.

Generic medicines account for roughly 90 percent of all prescriptions dispensed in the U.S. and are critical to our nation’s health care system and hundreds of millions of Americans. Unfortunately, the U.S. is dangerously dependent on foreign manufacturers—particularly in China and India—for essential, lifesaving generic medicines. The data paints an alarming picture. Currently, the U.S. is reliant on imports for at least two-thirds of our generic medicines, and nearly 90 percent of generic active pharmaceutical ingredient (API) facilities are overseas. The majority of those supply chains run through China and India.

This dependency has also increased generic drug shortages in the U.S. Nearly 50 percent of all pharmaceutical products on the FDA’s essential medicines list appear, in some form, on the FDA drug shortage list. A CBS News 60 Minutes special report documented how U.S. hospitals have been dealing with serious drug shortages for more than a decade.

According to the special report, “[d]uring a drug shortage, hospitals may be forced to switch patients to less safe or effective alternative drugs. They retrieve leftovers from single dose drug vials to share with other patients and avoid wasting a single drop.”

Americans for Safe Drugs recommends the following questions:

• Is the FDA considering action to prevent foreign manufacturers that have received multiple Warning Letters, especially in China and India, from exporting generic products to the U.S. until the FDA has conducted in-person inspections and ensured these facilities are operating in accordance with FDA regulations?

• Is the FDA currently testing, or is planning to test, imports of generic medicines from foreign manufacturers that are currently under Warning Letter to ensure these products are safe and effective?

• Is the FDA considering action that would prohibit retail and online pharmacies from selling generic medicines from foreign manufacturers that are currently under Warning Letter?

• With nearly 50 percent of all pharmaceutical products on the FDA’s essential medicines list appearing, in some form, on the FDA drug shortage list, has the FDA developed a plan to reduce U.S. dependence on foreign manufacturers and boost domestic production to address these shortages?

• Please provide the list of facilities in China and India that the FDA has inspected in the last 5 years.

• Please provide the list of facilities in China and India that have received a Warning Letter from the FDA in the last 5 years.

Earlier this year, Americans for Safe Drugs released a public poll of registered voters, conducted by Morning Consult, which shows that Americans overwhelmingly want to stop importing unsafe generic drugs. Key findings from the poll show that:

• 84% of Americans want the FDA to ban imports of generic medicines from foreign manufacturers that have received a Warning Letter.

• 86% of Americans support the FDA testing generic medicines imported into the U.S. from foreign manufacturers that have received a Warning Letter.

• 72% of Americans oppose importing generic medicines from China.

• 85% of Americans think it’s an important priority—with 43% saying it should be the top priority—for the U.S. government to establish the U.S. as a leader in the generic pharmaceutical manufacturing industry.

About Americans for Safe Drugs
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.

Americans for Safe Drugs is a campaign led by the Coalition for a Prosperous America.