AUSTIN, Texas — As the Trump administration moves forward with the approval of a dozen new high-dose drug candidates for cancer and other illnesses, there is concern that the FDA has yet to fully evaluate the safety and efficacy of these drugs.
The FDA has approved five high-cost drugs in recent weeks: two of which, called Sovaldi and Pfizer’s Pembrolizumab, are already approved for use in people who have advanced cancers.
However, the agency has also delayed approval of two of the drugs — one for cancer, the other for diabetes — pending an independent review of their safety and effectiveness.
Pfizer and Sovaldi are two of four new drugs being approved this week by the U.S. Food and Drug Administration, along with the rest of the approved drugs.
Both Pfizer and Avastin are being tested for cancer.
The other drug, Zantac, is being tested in people with advanced pancreatic cancer.
In a letter to FDA Commissioner Scott Gottlieb, Sen. Elizabeth Warren Elizabeth Ann WarrenWarren: Kavanaugh hearing reinforced national security concerns The ‘Fight for the American Dream’ should be bipartisan Elizabeth Warren says Kavanaugh hearing should be part of confirmation hearings MORE (D-Mass.) said the FDA should be more transparent about the progress of the new drugs.
“If the FDA is slow to approve drugs for cancer that have been proven to have cancer-preventing properties, why not make that information publicly available to the public?”
“If the agency doesn’t disclose its plans for approving these drugs, why are these drugs being made available for the first time in months?”
The FDA is not required to disclose the information it has for its approved drugs, but it has been doing so since December, when the agency approved the two new drugs for use to treat patients with advanced cancer.
“It is a sad state of affairs that this agency continues to withhold critical information about the drug development and testing process from the American people,” said David M. Bernstein, a former FDA deputy commissioner who is now at Boston College’s School of Public Health.
Bernstein also called on the FDA to disclose whether the agency is delaying the approval for new drugs or to release more information on the progress made in the development of the drug.
The agency’s latest approval of Pfizer-developed Pembolizumarab was delayed in October and the agency released a statement saying that the agency would “continue to evaluate the merits of the proposed approval” in the coming weeks.
The drug, which is being studied in patients with lung cancer and melanoma, has been approved for treating lung cancer.
Pembolinib is being investigated in patients diagnosed with metastatic pancreatic and liver cancers, according to the FDA.
Peprofumab is also being tested to treat lung cancer in people diagnosed with advanced melanoma and pancreatic cancers.
The drug, in Phase 2 clinical trials, has so far shown some promise for treating advanced melanomas.