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Pines Floats Six Ideas about FDA for Trump Administration Consideration

Dec. 6, 2016 – When the dust settles post-inauguration, the Trump administration likely will be considering how it might want ... read more

Sunshine Clarifications Stripped from 21st Century Cures Act

Special Report and Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director Nov. 30, 2016 – As ... read more

Kamp: Coalition Will Continue to Fight for Free Flow of Information

Nov. 28, 2016 – Although President-elect Donald Trump was not who the Coalition for Healthcare Communication was preparing for in ... read more

Coalition Meeting: Moving Forward in Washington, D.C.

Nov 18, 2016 – Although many in the medical marketing industry were bracing for a post-election drug pricing battle with ... read more

Kamp: Moving forward after the election

Nov. 11, 2016 – Post-election report from Coalition for Healthcare Communication Executive Director John Kamp: The pollsters and pundits sure ... read more

Speakers at FDA Off-label Hearing Call for Action that Protects Free Speech

Nov. 10, 2016 – As FDA Commissioner Robert Califf described the issues surrounding the communication of off-label uses as “numerous ... read more

Report from the Coalition Executive Director

Nov. 8, 2016 – When the votes are counted, expect many discussions on what will happen next. One thing is ... read more

Kamp to Urge FDA to Provide Clear Guidance on Off-label Communication at November Hearing

Oct. 31, 2016 – In testimony at the upcoming off-label hearing at the FDA, Coalition for Healthcare Communication Executive Director ... read more

Jenkins to Speak at CHC’s D.C. Meeting

Oct. 27, 2016 — Pam Jenkins, president of Powell Tate/Weber Shandwick, will be the keynote speaker at the Nov. 16 ... read more

Coalition Commentary: How Information Flows … or Doesn’t

Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director Oct. 25, 2016 – The Coalition for Healthcare ... read more

Kamp: Pharma Needs to Step up to Stem Opioid Abuse

Oct. 17, 2016 – In a recent guest commentary in PM360, Coalition for Healthcare Communication Executive Director John Kamp praised ... read more

CMS Clarifies Sunshine Act CME Exclusion

Oct. 6, 2016 – The Centers for Medicare & Medicaid Services (CMS) recently clarified in a revised FAQ that manufacturers ... read more

OPDP’s Abrams: Enforcement Still a Priority, Despite Decrease in Letters

Oct. 3, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has issued just four enforcement letters in ... read more

OPDP’s Second Enforcement Letter in Two Weeks Targets Investigational Drug

Sept. 15, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has only issued four enforcement letters this ... read more

OPDP Sends Enforcement Letter for Promotion of Investigational Drug

Sept. 8, 2016 — The FDA’s Office of Prescription Drug Promotion (OPDP) takes issue with a conference panel for an ... read more

FDA to Hold Post-election Hearing on Off-label Communication

Sept. 1, 2016 – In the wake of the agency’s recent settlement with Amarin and other rulings that support the ... read more

FDA May Still Issue Four Advertising Guidances in 2016

Aug. 11, 2016 — The FDA announced Aug. 10 that it plans to issue four, much-awaited advertising-related guidance documents before ... read more

Study Shows ACA Increases Use of Rx Drugs, Decreases Out-of-pocket Spending

Aug. 19, 2016 – The Affordable Care Act (ACA) has resulted in increases in the use of prescription drugs and ... 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

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

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

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

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

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

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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.