hile the FDA has in recent years relaxed regulations in certain areas — such as generic drug approval — advances like innovative new combination products (the use of a device and drug) continue to face stiff resistance from the agency. The Trump administration has been clear that any changes to the FDA regulatory structure are an effort to spur innovation by removing these hurdles. But how this will impact pricing and availability remains unclear.
David Fox, partner in the FDA Pharmaceutical and Biotechnology group at Hogan Lovells, believes that the changes likely to be proposed by the administration will create a very different landscape for manufacturers, healthcare companies, and consumers. He says clients in the drug and device space should consider four key areas.
- Relaxed regulation = healthy competition?
“Why is it that so many critical, life sustaining drugs in the United States are available from so few manufacturers? Is this an economic issue, or might it also be a regulatory one? If the new administration lowers the FDA’s regulatory barriers, its likely to encourage more manufacturers to enter the field.”
- Protectionist policies vs. foreign manufacturing
“About 80% of drugs sold in this country contain an active ingredient manufactured outside the US, with about 40% reportedly coming from China and India alone. One of the questions for the new administration is how it will reconcile the tension between increasing approvals of generic drugs, which means more foreign manufacturing, and establishing and enforcing potential new barriers to trade.”
- Freedom of speech
“Sponsors of therapeutic products like to disseminate scientific information about potential new uses for approved products. Historically, the FDA has ruled that this type of non-misleading scientific language can be unlawful if it supports a non-approved use of an approved product. Depending on the new administration’s stance on this issue, it could create a new flow of scientific information, which is very important for stimulating innovation.”
- Paving the way for combination products
“The FDA is very resistant to approving a combination (the use of a device and drug together) that would put a drug to new use without the drug company gaining compatible (new) drug labeling approved. Combination products therefore put device manufacturers in the position of having to either join forces with a drug company or themselves become a drug manufacturer, and most are not set up to do that. Under the new administration, we’re anticipating regulatory changes that will reduce these barriers. This will encourage device companies to continue searching for new uses for existing drugs. It’s a huge opportunity to advance the state of innovation.”
Watch the video to learn about other potential changes that could potentially reshape the FDA, and the impact they might have on drug and device manufacturers.
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