Megan Rose, ProPublica

Senators unleash crackdown after feds caught letting banned drug factories ship to US

Senators Propose Sweeping Changes to Generic Drug Oversight

by Debbie Cenziper and Megan Rose, ProPublica, and Melissa Dai, Medill Investigative Lab

ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox.

Series: Rx Roulette:The FDA’s Dangerous Gamble on America’s Drugs

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Lawmakers at the helm of the Senate Special Committee on Aging have proposed a sweeping series of changes that could transform the way the government safeguards the quality of essential generic drugs.

Citing a recent ProPublica investigation, the senators said the Food and Drug Administration should alert hospitals and other group purchasers when foreign drugmakers with serious safety and quality failures are given a special pass to send their products to the United States.

Since 2013, ProPublica found, the FDA quietly allowed more than 20 troubled overseas factories, mostly in India, to continue to send certain medications here even after those facilities were banned because of concerns about contamination and other breaches. The agency didn’t actively track whether the imported drugs were harming users and kept the practice largely hidden from the public and Congress.

In a recently released investigative report, the committee chair, Sen. Rick Scott, R-Fla., and ranking member Sen. Kirsten Gillibrand, D-N.Y., criticized the FDA for failing to notify Congress “in any way” about the practice, calling it a “failure on the FDA’s part to protect public health.”

Scott and Gillibrand also called on the FDA to conduct more testing of generic drugs rather than rely on assurances from foreign manufacturers that their medications are safe and effective. India supplies about half of all generic drugs used in the United States, and many of the key ingredients are produced in China, according to the report.

“The United States’ overreliance on foreign-made generic drugs, especially those made in adversarial nations, is a very real threat to all Americans, but especially our aging population,” Scott said.

The report marks a significant expansion of the senators’ bipartisan call to protect the U.S. drug supply.

After a hearing last month, Scott and Gillibrand demanded the FDA provide an immediate accounting of all foreign generic drugmakers allowed to skirt import bans. And last week, they sent a letter to Health and Human Services Secretary Robert F. Kennedy Jr. seeking a briefing about the drug supply chain and the risk of shortages. The letter also cited ProPublica’s reporting about the FDA’s exemptions from import bans, saying they could pose “a threat to drug safety for American consumers.”

The FDA has said that the exemptions were granted to prevent shortages and that manufacturers were required to conduct extra quality testing with third-party oversight to ensure the medications were safe.

HHS, which oversees the FDA, declined to comment about the investigative report or the letter to Kennedy when contacted by ProPublica, saying the agency would respond directly to the senators.

The 34-page report largely focuses on shoring up domestic manufacturing. The senators cited an academic study released this year that found generic drugs made in India were tied to far more hospitalizations, deaths and other adverse events than the equivalent medications manufactured in the United States.

“We let the industry go offshore for cost reasons without adjusting the regulatory infrastructure to be able to handle it appropriately,” said Ohio State University professor John Gray, who co-authored the study. “There’s this race to the bottom … that leads to fragility and shortages and also potential quality issues.”

Notably, the senators suggested the Department of Defense could help launch a “federal buyer’s market” that prioritizes the purchase of drugs from domestic manufacturers. The federal government, with agencies that include the Department of Veterans Affairs, is the largest purchaser of drugs in the United States.

The DOD is currently conducting its own testing of generic drugs widely used by American service members and has already reported finding potency and other quality issues.

“If these recommendations are put into action, then it really resets the table of the health care system in the United States,” said retired Army Col. Vic Suarez, who helped launch the DOD’s testing project. “When you combine all the federal agencies to do this in one aligned acquisitions strategy, it just has a really exponential impact that we’ve never seen before.”

The senators said if domestic manufacturing capacity is ramped up in the coming decade, federal purchasers could be required to buy drugs made in the United States with American-made ingredients.

The report also focused on transparency, saying that manufacturers should disclose on product labels the country where medications and their key ingredients are made.

“In the richest country in the world, our constituents shouldn’t have to worry about the safety and availability of the drugs they need to fight devastating diseases,” Gillibrand said.

New Pentagon rules keep many military court records secret

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In 2016, Congress passed a law that was supposed to make the military justice system more transparent, instructing the U.S. military’s six branches to give the public broader access to court records. Seven years later, the Department of Defense has finally issued guidelines for how the services should comply with the law, but they fall far short of the transparency lawmakers intended.

Caroline Krass, general counsel for the Defense Department, told officials from the Army, Navy, Air Force, Marines, Coast Guard and Space Force in a memorandum last month that they could mostly continue doing what they have been for years: keep many court records secret from the public.

In their 2016 law, lawmakers had envisioned a military justice system that operated much like federal courts, where the public has real-time electronic access to dockets, records and filings. Concerned about fairness and secrecy in the military system, Congress wanted the public to have similar access to records for courts-martial to allow for more scrutiny of how the military handles criminal cases, particularly sexual assault.

The law calls for the “timely” release of court records “at all stages of the military justice system ... including pretrial, trial, post-trial, and appellate processes.”

The newly released Pentagon guidance, however, does little to make the system more open. The guidance tells the services they do not have to make any records public until after a trial ends. It gives the military the discretion to suppress key trial information. And in cases where the defendant is found not guilty, the directive appears to be even more sweeping: The military services will be allowed to keep the entire record secret permanently.

The Pentagon did not respond to ProPublica’s questions about the new guidance. A Navy prosecutor argued in a court filing last year that the military cannot act like its counterparts in federal court because the military system doesn’t have a clerk of court and needs to be “fluid and mobile.”

Despite the 2016 law, which required consistent standards across the military, the Pentagon for years let the individual services decide how to comply with the law, and public access to court-martial records remained extremely limited.

Frank Rosenblatt, vice president of the National Institute of Military Justice, said even before the new guidance was issued, the spirit of the law wasn’t met. Leaving access decisions “to the discretion of military officials really is a default towards secrecy,” he said.

In September, ProPublica sued the Navy for refusing to provide nearly all of the court records in a high-profile arson case. The Navy prosecuted a sailor for allegedly setting the USS Bonhomme Richard on fire. In 2020, the amphibious assault ship burned for more than four days and was destroyed, a more than $1 billion loss. A ProPublica investigation showed there was little evidence of the sailor’s guilt, and Seaman Recruit Ryan Mays was found not guilty at his court-martial.

ProPublica’s lawsuit was successful in getting the Navy to release hundreds of pages of court-martial documents in the Mays case. The suit also challenges the Navy’s overall policy for withholding records and is ongoing. The lawsuit could end up questioning Krass’ new directive as well for not following the 2016 law or abiding by the First Amendment and judicial rulings that grant timely access to court records.

ProPublica’s lawsuit appears to have spurred the new Pentagon guidance. ProPublica, along with the Reporters Committee for Freedom of the Press and other media organizations, also wrote a letter to Krass requesting she outline standards for the military to follow. The National Institute of Military Justice supported ProPublica’s lawsuit and wrote a separate letter to Krass.

However, nothing in the new policy would force the Navy or the other services to release similar court records in the future.

The guidance allows the military to withhold records when public access and scrutiny is often most important: leading up to and during a court-martial. Under the new policy, the military doesn’t have to make records public until after a verdict is reached and the trial record is certified. The guidance says the services can take up to 45 days after certification to release any documents.

That arbitrary time frame is out of step with how every other court is run, Rosenblatt said. After a trial is over, “the newsworthiness is gone,” he said.

Even then, only a limited part of the trial record has to be produced. The services do not have to provide transcripts or recordings of court sessions or any evidence entered as exhibits, according to the Pentagon guidance. And the Pentagon does not consider any preliminary hearing documents to be part of the trial record.

In the military, there is a proceeding called an Article 32 hearing to decide whether there is enough evidence for a trial. Under the new guidance, the military won’t have to put these hearings on the docket, so the public won’t even know they are happening.

Records from Article 32 and other preliminary hearings tell the public a lot about whether the system is just. That’s where citizens can review and assess what cases the military are deciding to prosecute, Rosenblatt said.

In Mays’ case, for example, the judge who presided over the Article 32 hearing recommended that the Navy drop its case against him for lack of evidence. The Navy ignored that recommendation and moved forward with the prosecution. The service then refused to make that recommendation public.

The new Pentagon guidance also allows the military to permanently seal the trial record if the defendant is found not guilty. This could also prevent an assessment of fairness. For example, if a general is accused of sexual assault and found not guilty, the military doesn’t have to release any court records about the case, and the public would not be able to scrutinize how the case of a high-ranking officer was handled.

The new guidelines make one change in favor of transparency. The military will no longer use Freedom of Information Act exemptions to justify redacting information from court records. FOIA law is not used to withhold or redact court records in any other court in the country, and it was inappropriately applied in military courts, Rosenblatt said.

For example, in the Mays case, the Navy cited FOIA to redact the names of witnesses who testified in open court at trial.

Krass’ new guidance says that the 2016 law makes access to courts-martial records “distinct from the right” to federal records granted under FOIA. Instead the federal Privacy Act, which regulates how the government can collect and release information about private individuals, should guide “which information and documents from the military justice system are to be made accessible to the public.”

Although Rosenblatt said eliminating FOIA from the military judicial process was progress, the Privacy Act also doesn’t belong in the equation. The guidance also leaves how to interpret the Privacy Act and release of documents up to the services.

“The Privacy Act,” Rosenblatt said, “is increasingly being weaponized to shield what’s going on in the military justice system from the public.”