Oversight Committee Chairman Jason Chaffetz (R-UT) was joined by 12 committee members in a recent letter to U.S. Food and Drug Administration (FDA) Acting Director Stephen Ostroff requesting information and documents on the FDA’s generic drug application review process.
A wide range of stakeholders, including pharmacy benefits managers, pharmaceutical manufacturers, trade groups, insurance companies, the FDA, the U.S. Government Accountability Office, and the U.S. Department of Health and Human Services, met with the bipartisan Oversight Committee this year, highlighting declining competition in the marketplace as a result of barriers to entry for generic drugs, raising questions about the FDA’s review process.
“Generic drugs have historically played an important role in the health care marketplace by offering an alternative to brand drugs at a significantly reduced cost,” the letter said. “It is estimated that nearly 86 percent of all prescriptions filled in the United States are for generic drugs, with the average cost of generics typically 80 to 85 percent lower than their brand equivalents. Recent significant price increases for certain generic drugs, however, will make health care more expensive for patients, who will ‘pay more in copayments and premiums to cover the rising costs of drugs.’ Industry analysts have cited ‘declining market competition’ as one of the factors driving the recent prices increases. This raises questions about the efficiency of the Food and Drug Administration’s process for reviewing Abbreviated New Drug Applications (ANDA).”
The FDA will receive approximately $1.5 billion over five years from industry fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) to speed the public’s access to safe and effective generic drugs. As a result, the letter seeks documentation about the number of pending ANDAs and the FDA’s process for addressing and prioritizing such applications.
The letter also asks for documents related to the number of yearly ANDA submissions and yearly ANDA approvals since fiscal year 2012 and documents showing the number of pending ANDAs that have not been assigned target action dates.
Additionally, the letter notes that resale prices of priority review vouchers (PRV) have increased to $350 million over the past year from $67.5 million.
“Skyrocketing PRV resale prices, and the recent acquisition of KaloBios, have raised questions about potential exploitation of the PRV Program by those who may be applying for PRV not to develop new therapies but rather solely to capitalize on the PRV resale market,” the letter said. “Please provide all documents and communications referring or relating to any FDA investigation, FDA’s enforcement mechanisms to address such conduct, and steps by the FDA to prevent abuses of the PRV Program.”