By Kurt R. Karst —
Forty years ago today—on a sunny Monday, September 24, 1984 at approximately 3:30 PM Eastern Time in the Rose Garden at the White House—President Ronald Reagan signed into law Public Law 98-417, the Drug Price Competition and Patent Term Restoration Act of 1984, stating that “[t]he legislation will speed up the process of Federal approval of inexpensive generic versions of many brand name drugs, make the generic versions more widely available to consumers, and grant pharmaceutical firms added incentives to develop new drugs.” (Thanks to the Ronald Reagan Presidential Library & Museum and its White House Photo Collection Contact Sheets, you can see some of the enactment pictures here and here with President Reagan, Margaret Heckler, Strom Thurmond, Orrin Hatch, Henry Waxman, James (Jimmy) Quillen, and Ralph Regula.) Some would initially refer to the new law as Waxman-Hatch, but during the 1990s it became known as Hatch-Waxman. And that name has stuck for many of us.
There have already been (with more coming) a slew of 40th anniversary celebration papers, analyses, and events in 2024, including:
- The Brookings Institution’s Hatch-Waxman at 40
- The Association for Accessible Medicines’ Hatch-Waxman turns 40. Is it over the hill? (Or is the Hill over Hatch-Waxman…)
- The Engelberg Center on Innovation Law & Policy at NYU School of Law’s Health Care at Reasonable Cost: The Hatch-Waxman Act at 40 and Beyond
- The Food & Drug Law Institute’s Hatch–Waxman at 40: A Critical Examination of its Past and Future
- The American Academy of Neurology’s Happy Birthday, Hatch-Waxman: What 40 Years of Generic Drug Access Has Done for Neurology
- The Orrin G. Hatch Foundation’s For cheap generic drug prices, you can thank 40 years of Hatch-Waxman
- We Work For Health’s Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem
- Tradeoffs’ Race to the Bottom Series
- FDA CDER Conversations – 40th Anniversary of the Generic Drug Approval Pathway
- The U.S. Patent and Trademark Office’s Drug Patent and Exclusivity Study
Over the years we’ve celebrated various Hatch-Waxman milestones. For the 25th and 30th anniversaries, we held trivia contests (here and here). For the 40th anniversary of the Orange Book (and the quasi-35th anniversary of Hatch-Waxman), we put together a public Orange Book Archive (and it has become one of the more popular stops on the FDA Law Blog).
So what should we do here on the FDA Law Blog to celebrate the 40th anniversary of Hatch-Waxman? We thought about an interview with Rep. Waxman (sadly, Sen. Hatch passed away in April 2022), but Eli Mazour’s Clause8 podcast from October 2018 already covered that ground: see Henry Waxman – The Hatch-Waxman Act and a Life In Congress. We wanted something different . . . something useful to Hatch-Waxman practitioners. We thought long and hard, and then it came to us. We’ve done our best over the years to collect each Paragraph IV Certifications List FDA has published. (And, as you’ll see, sometimes we’ve captured multiple versions on the same day as FDA furiously changed some things around.) How about an archive of what is, next to the Orange Book, perhaps the second most relied on and viewed list associated with the Hatch-Waxman Amendments—FDA’s ANDA Paragraph IV Certifications List?!? That stuck with us, so we went ahead and created the ANDA Paragraph IV Patent Certifications List Archive.
The “PIV List” started out in the early 2000s as a pilot program FDA initiated in response to a July 27, 1999 Citizen Petition submitted by Biovail Corporation International (FDA Legacy Docket No. 1999P-2778) requesting that “FDA disclose to the public through its Web site (1) the name of the innovator drug and approved dosage strengths, (2) the date the first Paragraph IV-containing ANDA is submitted, and (3) the dosage strengths included in that ANDA.” On October 4, 2000, a second Citizen Petition (FDA Legacy Docket No. 2000P-1556) was submitted by Hyman, Phelps & McNamara, P.C., requesting, among other things, “that FDA disclose to the public through its Web site (1) the date on which the first Paragraph IV-containing ANDA was received by FDA, and (2) the patents to which ANDA applicants have made Paragraph IV certifications and the date of the first such certification for each patent.” FDA responded to the Citizen Petitions on February 27, 2004, and issued a Press Release on March 2, 2004 (yeah, we saved that as well) concerning the PIV List.
The Paragraph IV Certifications List began as a web-based list on FDA’s website, and eventually transformed into a PDF downloadable list. The most recent facelift to the PIV List occurred in June 2019 when FDA announced various enhancements (see our previous post here). Unfortunately, FDA’s PIV List does not track changes to each of the entries (except for a change in 180-day exclusivity status). And, as we recently noted, those entries can quietly change. So, our new ANDA Paragraph IV Patent Certifications List Archive (which we will add a link to on the FDA Law Blog homepage) will serve to preserve more Hatch-Waxman history.
Thank you Senator Orrin Hatch and Representative Henry Waxman! Your leadership and grit brought disparate parties together to benefit the public good (and has led to countless careers, including this blogger’s career)!
Oh, and what is this blogger’s memory of September 24, 1984? It was uneventful. I had just started 6th grade at Franklin Elementary School in Manitowoc, Wisconsin. Here’s the class picture for proof. You’ll have to find me in it . . . . Thank Gawd there’s some safety in numbers!
