Subscribe   RSS Contact Us

OPDP Issues Just Two Enforcement Letters in First Half of 2016

July 22, 2016 – Although 2015 was considered a slow year for enforcement letters issued by the FDA’s Office of ... read more

Gender and Healthcare Communications

By Nick Colucci, Publicis Health CEO July 21, 2016 — I was moved by a recent op-ed in The New ... read more

Medical Associations Support Bill Exempting Journals and Textbooks from Sunshine Reporting

July 15, 2016 – More than 100 medical associations, including the American Medical Association, signed a letter of support for ... read more

Pfizer Gets in Front of Opioid Marketing Issue

July 8, 2016 – As organized medicine, politicians and the public seek to reverse the scourge of opioid addiction, Pfizer ... read more

Bill Gates Defends U.S. Drug Pricing System

July 1, 2016 – Amidst criticism over the high cost of drugs in this country, billionaire and philanthropist Bill Gates ... read more

CEOs to Coalition’s Rising Leaders: Engage in Political Process, Keep Learning

June 17, 2016 – In order to stay ahead of change, further their careers and forward the positive message of ... read more

Washington Health Policy Focus Is on Drug Innovation, Reform and Pricing, Rawson Says

June 13, 2016 – Before and after the 2016 elections, Washington health policy will remain fixed on improving the path ... read more

Davidson Sums Up Past and Current State of DTC Ad Restrictions, Ad Tax Deduction

June 7, 2016 – The Advertising Coalition (TAC) Executive Director Jim Davidson gave industry’s next generation a comprehensive overview of ... read more

Courts’ Support for “Truthful and Non-misleading” Speech Has Not Yet Resulted in FDA Policy Change

May 31, 2016 – Although the U.S. Supreme Court and other courts consistently are deciding cases in favor of First ... read more

Congressman Jenkins to Coalition’s Rising Leaders: You Have the Power to Influence Lawmakers

May 24, 2016 – At a recent Coalition for Healthcare Communication Rising Leaders Conference, keynote speaker Rep. Evan Jenkins (R-W. ... read more

The Advertising Coalition Reminds FDA of First Amendment Limits to Advertising Regulation

May 9, 2016 – In an April 29 comment to the FDA on its recent proposal to conduct research on ... read more

Drug Companies Should Be Able to Share Information with Payers

May 2, 2016 – In order to make reasonable coverage decisions about new medicines, payers need access to information from ... read more

Commissioner of Food and Drugs Califf Lists Advertising, Labeling Among Priorities

April 25, 2016 — In a speech at the Alliance for a Stronger FDA’s quarterly meeting April 19, new Commissioner ... read more

NYTimes: Ban on Drug Ads Would Also Eliminate Ad Benefits

March 14, 2016 — The American Medical Association (AMA) as well as Rep. Rosa DeLauro (D-Conn.) and Sen. Al Franken ... read more

Sen. Franken Introduces Legislation to End Drug Advertising Tax Breaks

March 4, 2016 – Yesterday Sen. Al Franken (D-Minn.) introduced legislation that would end the tax deduction that drug companies ... read more

CHC and CCC Launching Regulatory Compliance University for Agencies, Publishers

Aug. 19, 2015 – The Coalition for Healthcare Communication (CHC) is partnering with the Center for Communication Compliance (CCC) to ... read more

Author of “Pharmaphobia” Says Conflict-of-interest Regulations Are Slowing Medical Progress

June 8, 2015 – In his new book, “Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation,” Tom ... read more

Previous Next

Kamp Commentary: Supreme Court Decision Could End “Pay for Delay”

April 1, 2013 – By John Kamp, Executive Director, Coalition for Healthcare Communication

While not directly about communication and marketing, last week’s oral argument in the U.S. Supreme Court in FTC v. Actavis regarding ANDROGEL could create a significant bottom line hit to our businesses.  A decision against pharma would further shorten the patent protection period on many branded drugs.

Here is a quick summary of the important legal and practical issues and what to watch for as the decision moves to Congress.

1. If the Supreme Court agrees with the Federal Trade Commission that “pay for delay” settlements are presumably illegal, they will nearly halt.

2. The Supreme Court is not deciding here what the Constitution means – where they have final authority – but only is deciding what the current commercial statutes require. Even if the Supreme Court agrees with pharma that such settlements are presumed valid under the existing antitrust and competition laws, Congress could invalidate that presumption by changing the law. Three such proposals have already been introduced.

3. The legal struggle is over three legal principles. Laws favor all three – patent protection, settlements over litigation, and vigorous competition. There are no easy choices here for the Supreme Court.

4. The biopharma industry seems to have the legal advantage. The FTC has struggled for more than a decade just to get this case to the Supreme Court and has lost more challenges on the way than it has won. The law supports settlements over litigation, even in antitrust cases. Further, one Justice recused himself, requiring the FTC to get five votes out of eight to prevail.

5. Also, Justice Kennedy, often seen as the swing vote, suggested during oral arguments that if Congress made a drafting mistake enabling these settlements in the Hatch-Waxman statute upon which the decision rests, it is up to Congress, not the courts, to change the law.

6. However, the FTC argued vigorously that the “pay for delay” drug patent settlements create extraordinary profits for the private companies. Further, it argued, these harm consumers much more than in any other antitrust settlement situation. The FTC asserted that the settlements create a legal anomaly whereby the generic challenger can make more money by settling than by winning and marketing the generic product. That’s because the settlement protects the monopoly pricing rather than speeding competition and lower prices to consumers.

7. Pharma faced tough questioning from skeptical judges, but so did the government. There is a good chance that the Supreme Court will support settlements in its decision, but either way, Congress can change the Hatch-Waxman statute to disfavor them.

8. Meanwhile, the populist policy and politics favors drug cost savings, especially in the face of escalating healthcare costs and the need to control the growing deficit. Although the law seems to favor pharma, especially with the more conservative justices, the politics of less expensive drugs may be tougher, especially as the case moves to Congress.

9. Don’t count the industry out yet. Biopharma and device companies have an unusual ally in this fight: generic drug companies and their associations. Also, the Pharmaceutical Research and Manufacturers of America (PhRMA) and its allies have had some recent success reminding Congress that innovative drugs require patent protection and the profits that brings to rebuild drug pipelines and enable the advance of modern medicine. Laws flying in the face of that common sense argument are not slam-dunks.

Stay tuned.