Hostname: page-component-cd9895bd7-dzt6s Total loading time: 0 Render date: 2024-12-23T04:01:50.116Z Has data issue: false hasContentIssue false
  • English
  • Français

Promoting Competition in Drug Pricing: A Review of Recent Congressional Legislation

Published online by Cambridge University Press:  10 January 2022

Sarosh Nagar  and
Aaron S. Kesselheim
Get access Rights & Permissions [Opens in a new window]

Abstract

Brand-name prescription drug manufacturers use various strategies to extend their market exclusivity periods by delaying generic or biosimilar competition. Recent Congressional legislation has targeted four such tactics. We analyze these proposals and assess their likely effect on competition in the U.S. drug market.

Keywords

Drug PricesPatentsProductHoppingGeneric Drug
Type
Columns: Health Policy Portal
Information
Journal of Law, Medicine & Ethics , Volume 49 , Issue 4: First Amendment Values in Health Care , Winter 2021 , pp. 683 - 687
Copyright
© 2021 The Author(s)

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

About This Column

Aaron Kesselheim serves as the editor for Health Policy Portal. Dr. Kesselheim is the JLME editor-in-chief and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women’s Hospital/Harvard Medical School. This column features timely analyses and perspectives on issues at the intersection of medicine, law, and health policy that are directly relevant to patient care. If you would like to submit to this section of JLME, please contact Dr. Kesselheim at [email protected].

References

Kesselheim, A.S., Avorn, J., and Sarpatwari, A., “The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform,” JAMA 316, no. 8 (2016): 858–871, doi:10.1001/jama.2016.11237.CrossRefGoogle ScholarPubMed
Id.Google Scholar
R. Conrad and R. Lutter, “Generic Competition and Drug Prices: New Evidence Linking Greater Generic Competition and Lower Generic Drug Prices,” Food and Drug Administration, available at <https://www.fda.gov/media/133509/download> (last visited November 8, 2021).+(last+visited+November+8,+2021).>Google Scholar
Id.Google Scholar
Vokinger, K.N., Kesselheim, A.S., Avorn, J., and Sarpatwari, A., “Strategies That Delay Market Entry of Generic Drugs,” JAMA Internal Medicine 177, no. 11 (2017): 1665–1669, doi:10.1001/jamainternmed.2017.4650; O. Dyer, “Allergan Transfers Restasis Patent to Mohawk Tribe to Deter Challenges from Generics,” BMJ 358 (2017): j4280, doi:10.1136/bmj.j4280.CrossRefGoogle ScholarPubMed
Cheng, J., “An Antitrust Analysis of Product Hopping in the Pharmaceutical Industry,” Columbia Law Review 108, no. 6 (2008): 1471–1515.Google Scholar
Noah, L., “Product Hopping 2.0: Getting the FDA to Yank Your Original License Beats Stacking Patents,” Marquette Intellectual Property Law Review 19, no. 2 (2015): 161–179.Google Scholar
Carrier, M.A. and Shadowen, S.D., “Product Hopping: A New Framework,” Notre Dame Law Review  92, no. 1 (2016): 167– 230; Federal Trade Commission v. Reckitt Benckiser Group PLC. 2019. Case No. 1:2019cv00028. Complaint. July 11.Google Scholar
Carrier, supra note 8; Federal Trade Commission, supra note 8.Google Scholar
Carrier, supra note 8.Google Scholar
Capati, V.C. and Kesselheim, A.S., “Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine,” Journal of Managed Care & Specialty Pharmacy 22, no. 4 (2016): 339–344.CrossRefGoogle ScholarPubMed
Id.Google Scholar
Noah, supra note 7.Google Scholar
H.R.2873 – 117th Congress (2021-2022): Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, H.R.2873, 117th Cong. (2021), available at <https://www.congress.gov/bill/117th-congress/house-bill/2873> (last visited November 9, 2021).+(last+visited+November+9,+2021).>Google Scholar
Avery, M., Newsom, W., and Hahn, B., “The Antitrust Implications of Filing ‘Sham’ Citizen Petitions with the FDA,” Hastings Law Journal 65, no. 1 (2014): 113–152.Google Scholar
Kesselheim, supra note 1; Carrier, M.A. and Minniti, C., “Citizen Petitions: Long, Late-Filed, and at-Last Defined,” American University Law Review 66, no. 2 (2016): 305–352.Google Scholar
Kesselheim, supra note 1; Avery, supra note 15; Carrier, supra note 16. Google Scholar
Carrier, supra note 16.Google Scholar
Kesselheim, supra note 1; Vokinger, supra note 5; Feldman, R. and Wang, C., “A Citizen’s Pathway Gone Astray — Delaying Competition from Generic Drugs,” NEJM 376, no. 16 (2017): 1499–1501, doi:10.1056/nejmp1700202.CrossRefGoogle ScholarPubMed
Haffajee, R.L. and Frank, R.G., “Abuses of FDA Regulatory Procedures — The Case of Suboxone,” NEJM 382, no. 6 (2020): 496–498, doi:10.1056/nejmp1906680.CrossRefGoogle ScholarPubMed
Id.Google Scholar
Id.Google Scholar
Feldman, R., Frondorf, E., Cordova, A. K., and Wang, C., “Empirical Evidence of Drug Pricing Games-A Citizen’s Pathway Gone Astray,” Stanford Technology Law Review 20, no. 1(2017): 39–53.Google Scholar
H.R.2883 – 117th Congress (2021-2022): Stop Stalling Access to Affordable Medications, H.R.2883, 117th Cong. (2021), available at <https://www.congress.gov/bill/117th-congress/house-bill/2883> (last visited November 9, 2021).+(last+visited+November+9,+2021).>Google Scholar
Holman, C., “Do Reverse Payment Settlements Violate The Antitrust Laws,” Santa Clara Computer & High Technology Law Journal 23, no. 3 (2007): 489–587.Google Scholar
Kesselheim, A.S., Murtagh, L., and Mello, M.M., “‘Pay for Delay’ Settlements of Disputes over Pharmaceutical Patents,” NEJM 365, no. 15 (2011): 1439–1445, doi:10.1056/nejmhle1102235.CrossRefGoogle ScholarPubMed
Id.Google Scholar
Dyer, O., “Generic Drug Firm Settles Claim that it was Paid to Stay Out of Market,” BMJ 350 (2015), doi:10.1136/bmj.h2282; R. Feldman “The Price Tag of ‘Pay-for-Delay’,” UC Hastings Research Paper Forthcoming, available at <https://ssrn.com/abstract=3846484> (last visited November 9, 2021).Google ScholarPubMed
Feldman, supra note 28.Google Scholar
Carrier, M., “The Rule of Reason in the Post-Actavis World,” Columbia Business Law Review 2018, no. 1 (2018): 1–25; FTC v. Actavis, Inc., 133 S. Ct. 2223, 570 U.S. 136, 186 L. Ed. 2d 343 (2013).Google Scholar
“Health Policy Brief: Patent Settlements,” Health Affairs, July 21, 2017, DOI: 10.1377/hpb20170721.583967.CrossRefGoogle Scholar
Feldman, supra note 28; Karas, L., Anderson, G., and Feldman, R., “Pharmaceutical ‘Pay-for-Delay’ Reexamined: A Dwindling Practice or a Persistent Problem?” Hastings Law Journal 71, no. 4 (2020): 959–974.Google Scholar
Feldman, supra note 28.Google Scholar
Feldman, supra note 28Google Scholar
H.R.2891 – 117th Congress (2021-2022): Preserve Access to Affordable Generics and Biosimilars Act, H.R.2891, 117th Cong. (2021), available at <https://www.congress.gov/bill/117th-congress/house-bill/2891> (last visited November 9, 2021).+(last+visited+November+9,+2021).>Google Scholar
Li, Y., “Does It Still Take Two to Tango? A Modern Interpretation of the BPCI’s Patent Dance,” NYU Journal of Intellectual Property and Entertainment Law 9, no. 1 (2020): 107–138.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Alsup, J.M., “You Can Dance If You Want to-Initial Interpretations of BPCIA’s Patent Dance with Sandoz and Amgen,” Hastings Science & Technology Law Journal 8, no. 2 (2016): 137–157.Google Scholar
Li, supra note 36; Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664, 198 L. Ed. 2d 114 (2017); 35 U.S.C. § 271(e)(6).Google Scholar
H.R.2884 – 117th Congress (2021-2022): Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act, H.R.2884, 117th Cong. (2021), available at <https://www.congress.gov/bill/117th-congress/house-bill/2884> (last visited November 10, 2021).+(last+visited+November+10,+2021).>Google Scholar
Li, supra note 36; Id.Google Scholar
FTC v. Shire ViroPharma Inc, (3d Cir. 2019) (PRECEDENTIAL OPINION Coram: SMITH, Chief Judge, MCKEE and FISHER, Circuit Judges. Total Pages: 36. Judge: SMITH Authoring.), available at <https://www.govinfo.gov/app/details/USCOURTS-ca3-18-01807/USCOURTS-ca3-18-01807-0> (last visited November 10, 2021).+(last+visited+November+10,+2021).>Google Scholar
Feldman, supra note 19; Haffajee, supra note 20.Google Scholar
Preserve Access to Affordable Generics and Biosimilars Act, supra note 35.Google Scholar
Health Policy Brief: Patent Settlements, supra note 31.Google Scholar
Carrier, supra note 6.Google Scholar
Affordable Prescriptions for Patients Through Promoting Competition Act, supra note 13.Google Scholar