Glaucoma 360 New Horizons Forum

Glaucoma 360 New Horizons Forum

Source:

Chambers W. Update with FDA leaders. Presented at: Glaucoma 360 New Horizons Forum; Jan. 30, 2021 (virtual meeting).

Disclosures: Chambers and Singh report no relevant financial disclosures.
February 10, 2021
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Compounded glaucoma therapies can reduce medication shortages, prices

Source:

Chambers W. Update with FDA leaders. Presented at: Glaucoma 360 New Horizons Forum; Jan. 30, 2021 (virtual meeting).

Disclosures: Chambers and Singh report no relevant financial disclosures.
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Compounded off-label glaucoma therapies can reduce medication prices and lead to more widespread treatment, according to a speaker.

The FDA has curbed an initiative to have all effective but unapproved compounded drugs approved by the agency, Wiley A. Chambers, MD, supervisory medical officer of new drugs at the FDA, said at the virtual Glaucoma 360 New Horizons Forum.

Wiley A. Chambers

“The downside we found in many cases was when old products were approved and came to the market with a new drug application, there would be a rise in the price to that particular product. That rise was then causing difficulties as far as availability for that product,” he said.

Chambers spoke on the initiative after discussion moderator Kuldev Singh, MD, MPH, asked about effective off-label ophthalmic uses of drugs, such as mitomycin C used adjunctively with glaucoma filtration surgery, and their continued use when an FDA-approved alternative is available.

Approved products frequently see improved manufacturing capability and consistency after going through the regulatory system, but that may also pose a downside, Chambers said.

“The agency has stopped that initiative and is no longer pushing for those unapproved products to come to market. The other thing that happened with that is once something got approved, they would then ask us to go and remove all of the unapproved products. This could sometimes contribute to shortages and cost increases, and it limited the availability of some of the products,” Chambers said.

The FDA is still approving alternatives to compounded therapies if a company submits an NDA, but it is no longer pushing to get rid of the unapproved alternatives, he said.

The practice of medicine allows a physician to prescribe what they believe is in the best interest of a patient and for a pharmacy to fill that prescription, Chambers said.