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AMA Calls for DTC Advertising Ban

Nov. 17, 2015 — The American Medical Association (AMA) announced today that it would support an advertising ban on direct-to-consumer ... read more

Rocky Political Road Ahead for Pharma Industry

Nov. 16, 2015 – From tax inversions to the proposal to reduce ad tax deductions for marketing to being named ... read more

PhRMA Puts Drug Costs in Perspective as Pricing Scrutiny Increases

Nov. 9, 2015 – Congress, federal agencies and the media continue to turn up the heat on their examination of ... read more

Kaiser Poll: DTC Ads Have High Profile, But Mixed Reviews

Oct. 30, 2015 – The drug industry may have additional work to do to improve the public’s perception of its ... read more

CHC DC Meeting: Prescription Drugs Are Cost Savers, Not Cost Drivers

Oct. 26, 2015 – There is no question that prescription drugs have a cost to patients and payers, but that ... read more

FDA Study of DTC Ads Reaches Critical Mass

Oct. 20, 2015 – The FDA’s announcement last week that it was accepting comments on two new studies of direct-to-consumer ... read more

Senate Bill Would Loop Nurse Practitioners and PAs into Sunshine Reporting

Oct. 12, 2015 – A bill introduced in the Senate last week by Sen. Charles Grassley (R-Iowa) and Sen. Richard ... read more

Which Standard of Truth Will Be Used To Evaluate Non-misleading Ad Claims?

Oct. 5, 2015 – Following numerous First Amendment court cases about promotional speech decided in favor of pharmaceutical companies, it ... read more

Prescription Drug Marketing Targeted by Hillary Clinton

Sept. 24, 2015 – Presidential hopeful Hillary Clinton just announced that she would “demand a stop to excessive profiteering and ... read more

CMPI: Value of Prescription Drugs Is Underestimated

Sept. 21, 2015 – Despite widespread reports about the soaring prices of prescription drugs and calls by the federal government ... read more

Pacira Files Complaint Calling FDA Marketing Restrictions Unconstitutional

Sept. 10, 2015 – On the heels of last month’s ruling in Amarin v. FDA, which held that the FDA ... read more

Comment Period for Brief Summary Revised Guidance Extended to Oct. 5 Under Second Revision

Sept. 8, 2015 – To incorporate animal prescription drugs into its revised draft guidance on Brief Summary and Adequate Directions ... read more

Pitts Calls Higher Drug Approval Rate a Sign of Regulatory Progress

Aug. 24, 2015 – Although some may call the FDA to task for approving more new drugs than they have ... 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

Kamp on Presidential Politics: They Matter to Medical Marketers

Aug. 17, 2015 – In an Aug. 11 column posted on the PharmaLive website, Coalition for Healthcare Communication Executive Director ... read more

Amarin Federal Court Decision: FDA Off-Label Marketing Rules Violate the First Amendment By John Kamp

Aug. 10, 2015 – Late last week the U.S. District Court for the Southern District of New York granted Amarin ... read more

FDA Will Study How Market Claims, Efficacy Info Affect Consumers in DTC Drug Print Ads

July 29, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) recently announced that it plans to conduct a ... read more

Congressional Briefing: Medical Information Communication Is Important Patient Issue

July 28, 2015 – Physicians and their patients need access to truthful and non-misleading data about available treatments, including off-label ... read more

CME Update: CMS Revises Guidance and Industry Ups Spending

July 20, 2015 – Two recent developments in the continuing medical education (CME) arena – a revision to CME guidance ... read more

Kamp: 21st Century Cures Act and Amarin Case Developments Are Signs of Progress

July 13, 2015 –Two events last week – the House approval of the 21st Century Cures legislation and arguments in ... read more

House Approves 21st Century Cures Act, Bill Now Heads to the Senate

July 10, 2015 — The House of Representatives today passed H.R. 6, also known as the 21st Century Cures Act, ... read more

21st Century Cures Legislation Garners House Majority Support

July 1, 2015 – The 21st Century Cures Act, which was unanimously approved by the House Energy and Commerce Committee ... read more

Google SEM Changes Affect Drug Black Box Reminder-like, Redirecting Ads

June 29, 2015 – Two changes to search engine marketing (SEM) recently announced by Google could soon alter how pharmaceutical ... read more

Physicians Say CHC-backed H.R. 293 Would Remedy “Burdensome” Sunshine Act Reporting

June 15, 2015 – More than 100 physician organizations have written to Rep. Michael Burgess (R-TX) to express their strong ... 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

Revised Guidance on Use of Brief Summary in Print DTC Ads: Full PI Is Not Needed or “Recommended”

Feb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version ... 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.