Lawmakers suggested more generic competition was needed to drive down prices of Mylan’s EpiPen and asked Dr. Woodcock why some approved forms of epinephrine are not marketed like EpiPens, according to the Morning Consult.
Dr. Woodcock said that Mylan’s EpiPen patents, which last until 2025, hold off a large amount of generic competition. Some companies with approved epinephrine auto-injectors have had to pull their products off the market because of performance problems, she said.
Dr. Woodcock also explained that the FDA rarely approves a new generic drug on its first application.
“It’s possible to approve drugs very rapidly if in fact the application meets our standards, but we can’t approve substandard generic drugs,” she said. “It would erode the confidence of the public in the generic drug program.”
She warned the committee that implementing an over-complicated bill to promote generic competition could potentially slow down the regulatory process and give drug companies more loopholes to delay competition from hitting the market.
More articles on supply chain:
Sarepta’s drug approval: The rise of consumer input or the fall of drug standards?
Mylan CEO’s mother advocated for EpiPen sales in school as education leader
Senate committee to examine Mylan’s Medicaid rebates
