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# FDA Reform Needed to Address Lack of Urgency: Forbes
- URL: https://www.fdaweb.com/fda-reform-needed-to-address-lack-of-urgency-forbes/
- Published: 2022-07-18T12:00:00.000Z
- Updated: 2026-09-14T17:52:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152302

FDA’s alleged foot dragging in recommending updated Covid-19 vaccines [last month](https://www.fdaweb.com/add-omicron-ba-4-5-component-to-boosters-fda/) and in [approving the release](https://www.fdaweb.com/inspection-of-denmark-monkeypox-vaccine-facility-completed/) of new Monkeypox vaccines illustrates the need to reform the agency, according to a 7/18 *Forbes* [article](https://www.forbes.com/sites/sallypipes/2022/07/18/its-time-to-cure-the-fdas-regulatory-sclerosis/?sh=4a4f6b7d175c&ref=fdaweb.com) by Pacific Research Institute president **Sally Pipes** in which she takes issue with what she describes as the agency’s insufficient urgency in dealing with the Covid emergency, which it risks repeating with Monkeypox outbreaks.

“It’s been roughly six months since omicron caused [COVID cases](https://www.nytimes.com/interactive/2021/us/covid-cases.html?ref=fdaweb.com) to spike,” she writes. “Yet the FDA waited until a new, more transmissible version of the virus was threatening a wave of cases and reinfections to recommend updating the vaccines, which are based on a two-year-old version of the virus that bears [less and less resemblance](https://www.theguardian.com/world/2022/jul/05/new-covid-variants-ba4-ba5-most-contagious-australia-third-omicron-wave-coronavirus-subvariants-ba-4-5?ref=fdaweb.com) to today’s offshoots.”

By the time the revamped vaccines are available beginning in October, the current surge will have long peaked, Pipes complains. “The science is not the problem,” she says, “but the regulatory state is. As soon as scientists identified omicron last fall, Moderna and Pfizer started working on reformulating their shots to target its BA.1 variant. More than 200 days later, the FDA [hadn’t met](https://www.bostonglobe.com/2022/06/06/nation/omicron-booster-shots-are-taking-longer-than-expected-will-wait-be-worth-it/?ref=fdaweb.com) to discuss the new vaccines. By the time the agency’s vaccine advisors finally convened last month, BA.4 and BA.5 were the dominant strains. That [forced vaccine-makers](https://thezvi.substack.com/p/covid-63022-vaccine-update-update?utm%5Fsource=substack&utm%5Fmedium=email) to pivot and create new formulas for their shots.”

In the article, Pipes also turns to the recently stalled user fee reauthorization, specifically lawmakers’ actions to revamp the accelerated approval process, which she says could lead to ensnaring it in more red tape. “As midterm elections approach, FDA reform should be on the ballot,” she says. “Lawmakers would do well to advance policies that would cure the agency's sclerosis.”