Whose responsibility is it to build confidence in both the pharmacovigilance process as well as the urgent importance of the proposition? It’s the job of the regulatory body that oversees the both the procedures and the actions that derive from post-marketing reports. That means the FDA.
Whose responsibility is it to build confidence in both the pharmacovigilance process as well as the urgent importance of the proposition? I believe it’s the job of the regulatory body that oversees the both the procedures and the actions that derive from post-marketing reports. That means the FDA.
Small is the new Big means we must think differently about pharmacovigilance. While we must continue to capture adverse event data, we must also strive to capture Substandard Pharmaceutical Events (SPEs). SPEs occur when a product does not perform as expected—perhaps because of API or excipient issues. SPEs can arise because of an issue related to therapeutic interchangeability. When it comes to 21st-century pharmacovigilance, we have to both broaden and narrow our views about bioequivalence to the patient level.
The FDA is establishing an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic and over-the-counter drugs, CDER Director, Dr. Janet Woodcock said at the Bloomberg health-care summit. The FDA is talking with the industry to develop data that may signal which manufacturing plants are straying from standards and need inspection, she said.
The agency now collects such information only during inspections. The thrust of the effort would be to head off potential concerns before the agency wields penalties such as banning products from troubled factories. “We want to use leading indicators. These people aren’t in trouble yet but they could be.”
Per Peggy Hamburg, “All companies must understand that quality is the basis for the public’s trust and confidence in their products and maintaining high quality standards is part of the cost of doing business.” Hamburg said the new office will “improve our oversight of quality throughout the lifecycle of a pharmaceutical product.”
Congressional hearings are scheduled to hear from doctors, researchers and patient advocates Feb. 26 in a briefing on whether substandard generic drugs are reaching the U.S. medical system from overseas. The briefing will feature Harry Lever, a Cleveland Clinic cardiologist who has said generic drugs for heart failure made by India-based companies often don’t work the way they should.
The FDA is working with groups such as the Pharmaceutical Research and Manufacturers of America and American Association of Pharmaceutical Scientists to determine how often it will ask drugmakers to submit quality data.
Small is the new Big. That’s big news – and it’s about time.