Previous episodes of the All Access podcast have featured Jeff Watson (Apotex), Anthony Principi (board member, Golden State Medical Supply, and former secretary of the Veterans Administration), Avik Roy (Foundation for Research on Equal Opportunity) Vinita Gupta (Lupin Ltd.), industry veteran Bob Billings, and my AAM colleagues Monét Stanford & Lisa Parks. We very much look forward to continuing these fascinating, educational dialogues and hope you’ll tune in.
Our All Access conversation with Robert Pollock, M.S., Senior Advisor, Outside Director to the Board at Lachman Consultants took place before a “live studio audience” during the 2021 virtual GRx+Biosims event. Bob’s appearance at the premier scientific and regulatory event for the U.S. generics and biosimilars industry marked the 37th anniversary of the Hatch-Waxman Amendments that gave rise to the industry. Bob worked at FDA in the earliest days of Hatch-Waxman and was among the very first employees of the new division of generic drugs.
In his view, the generics and biosimilars industry is saving people's lives by making products available so they can take them.
This pioneer on the regulatory side of our industry joined FDA shortly after the legislation passed, starting as Consumer Safety Officer and moving up through the ranks to become Acting Deputy Director of the Office of Generic Drugs. Regarding balance between the brand-name companies and the generic manufacturers, Bob said, Both parties got something, everybody had to give up something, but it worked.
According to Bob’s recollection, the initial avalanche of generic drug applications was so great that they stacked up so high that, standing at the door of some of the offices, you couldn't see if a person was sitting at the desk.
He describes those early days as organized confusion.
Throughout his tenure at FDA, Bob continued to work as a pharmacist. Later, during his 26 years with Lachman, Bob’s work covered science, technology and regulatory activities in pharmaceutical, biologics, diagnostic device and allied health industries. He noted that compliance is the firm’s largest practice area. He also pens most of the entries for Lachman’s blog.
#AllAccessPodcast w/Bob Pollock @LachmanConsult: “I don't know why everybody keeps picking on #generics b/c the profit margin's so small...some of the smaller firms get driven out of the market. So, I really think that generics get a bad rap.” https://t.co/WhOVqMDdLH @DLeonard_DC pic.twitter.com/3ZwWy0sJYn
— AAM (@AccessibleMeds) November 25, 2021
Published on November 30, 2021