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FDA Reform

Here is how the FDA must be reformed to ensure the United States is far more prepared for a future pandemic, and ensure that essential medicines are safe, affordable, and readily accessible for all Americans.

The FDA is responsible for ensuring the safety and effectiveness of drugs sold in the U.S., regardless of where they are produced.

The problem is not the regulations themselves, but the FDA’s lack of enforcement of them—especially lack of enforcement for foreign drug manufacturers in China and India. Overseas manufacturers have a long history of evading the bulk of the FDA’s oversight, as the agency’s inspectors have no statutory authority abroad and their ability to inspect facilities is restricted to the level of access that foreign countries and companies are willing to provide.

 

The FDA’s uneven enforcement of its authority has created a multibillion-dollar regulatory loophole for overseas manufacturers that undermines the agency’s ability to protect the American people. It incentivizes companies to shift production the countries beyond the reach of the FDA’s more rigorous inspections. The consequence is less resilient pharmaceutical supply chains, and more American people exposed to potentially substandard, harmful, and even lethal generic drugs.

 

Here is how the FDA must be reformed to ensure the United States is prepared for a future pandemic and essential medicines are safe, affordable, and readily accessible for all Americans.

FDA

Warning Letters

❌  PROBLEM:

Chinese and Indian manufacturers receive the most FDA warning letters for violations of good manufacturing practices which can result in unsafe generic drugs. Companies that have received multiple warning letters are often allowed to continue to sell their generics to the American people.

SOLUTION:

Prevent foreign manufacturers that have demonstrated a pattern of disregard for FDA regulations, especially in China and India, from exporting generic products to the U.S. — and bar retail and online pharmacies from selling them until facilities are operating in accordance with FDA regulations.

Unsafe, Substandard Drugs

❌  PROBLEM:

Foreign facilities in China and India have received Warning Letters for violating FDA’s safety regulations, including violations of hair in a vial, carcinogens in medicines, and manufacturing processes that are not sterile.

✓ SOLUTION:

The FDA should test drugs from foreign manufacturers that have received multiple Warning Letters to ensure the products are safe and effective. Additionally, the FDA should ban imports from these foreign facilities until the deficiencies cited in the Warning Letters are resolved.

FDA Inspections

❌  PROBLEM:

The FDA hasn’t inspected foreign manufacturers in China and India that are under Warning Letter since 2019. Incredibly, they have suggested virtual inspections rather than in-person inspections.

✓ SOLUTION:

Prioritize and increase inspections of foreign facilities in China and India, especially manufacturers that have received multiple Warning Letters, to ensure these facilities are safe and operating in accordance with the FDA’s standards.

Price Gouging

❌  PROBLEM:

Foreign manufacturers in China and India undercut U.S. producers to drive them out of the market and monopolize the industry. Then they raise prices dramatically—up to 2000%—gouging Americans.

✓ SOLUTION:

 Implement policies to bring generic drug manufacturing back to the United States, increase competition and rebuild America’s pharmaceutical industrial base.

Shortages of Lifesaving Drugs

❌  PROBLEM:

America’s dangerous reliance on foreign manufacturers in China and India has contributed to widespread drug shortages. The data outlining America’s reliance on foreign manufacturers is shocking: over two-thirds of generic drugs and 87 percent of generic APIs are made abroad.

✓ SOLUTION:

Implement policies to reshore U.S. domestic manufacturing of generic drugs by leveraging the federal government’s buying power, implementing supportive trade policies, and providing financial incentives to give domestic manufacturers the certainty they need to rebuild America’s pharmaceutical industrial base.