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Mark Shields to Share Political Insight at Coalition’s D.C. Meeting Sept. 23

Sept. 15, 2014 – Political analyst Mark Shields will be the keynote speaker at the Coalition for Healthcare Communication’s Washington ... read more

CMS Bombarded with Comments Calling for CME Exemption to Remain

Sept. 9, 2014 – An overwhelming majority of comments sent to the Centers for Medicare & Medicaid Services (CMS) by ... read more

Coalition Comment to CMS: Keep CME Exemption Under Sunshine Act

Sept. 2, 2014 – The Coalition for Healthcare Communication’s comment to the Centers for Medicare & Medicaid Services (CMS) asks ... read more

Open Payments Website Reopened, Dispute Period Extended and One-third of Records Withheld

Aug. 18, 2014 – The Centers for Medicare & Medicaid Services (CMS) recently announced that it had reopened its Open ... read more

Medical Groups Ask CMS to Make Changes to Sunshine Act Implementation

Doctors Recommend Fixes to CME Exemption Elimination, Educational Materials Provision Aug. 6, 2014 – More than 100 medical associations and ... read more

Doctors and Industry: When Sharing Sunshine Data, Context Matters

July 29, 2014 – Industry groups and physician organizations have banded together to petition the Centers for Medicare & Medicaid ... read more

Doctor Tells Congress That Communication Is Hampered by FDA, CMS Practices

July 28, 2014 – FDA and Centers for Medicare & Medicaid Services (CMS) policies are barriers to ongoing evidence development ... read more

FDA Plans to Study Effect of DTC Ads on Adolescents

July 24, 2014 – A better understanding of how adolescents weigh risks and benefits in direct-to-consumer (DTC) ads is needed ... read more

Bruce Grant Urges Pharma Communicators to Recognize Their Role in Health Advances

July 23, 2014 – Although the pharmaceuticals industry has come under fire in recent years, it is important to remember ... read more

FDA Social Media Draft Guidances Answer Some Questions, Raise Others

July 21, 2014 – Although the FDA has attempted to provide some clarity on its position regarding certain social media ... read more

Kamp to Washington Post: Companies Should Be Able to Speak Truthfully About Drugs

July 14, 2014 – Drug companies should be allowed to share truthful information about the off-label uses of their drugs, ... read more

CMS Proposes Eliminating CME Sunshine Act Exemption

July 7, 2014 – About 240 pages into the 600-page physician fee schedule proposed rule, which is due to be ... read more

FDA Device Document Revises Mobile Medical Apps Guidance

July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ... read more

New FDA Social Media Guidances Address Space-limited Media, Correcting Online Misinformation

June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) ... read more

AMA House of Delegates: Revise Sunshine Act Rules on Textbook/Reprints and TOV Amount

June 12, 2014 – The American Medical Association’s (AMA’s) House of Delegates is attempting to bring some common sense to ... read more

As Sunshine Act Phase One Implemenation Ends, Compliance Concerns Grow

June 9, 2014 – In a recent Pharmalot blog post on The Wall Street Journal site, Ed Silverman writes that ... read more

House Committee Seeks Patient Input on Availability of Treatments

June 3, 2014 – The House Energy and Commerce Committee is seeking public comments from patients, providers and other stakeholders ... read more

FDA To Study Viewers’ Responses to DTC Ad Risk Information

May 29, 2014 – The FDA announced May 28 in the Federal Register that it plans to conduct an eye ... read more

FTC Calls for Data Broker Legislation To Protect Consumers

May 29, 2014 – The Federal Trade Commission (FTC) released a report May 27 in which it asks Congress to ... read more

OPDP Enforcement Letters Address Omission of Risk Information

May 23, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued just three Untitled Letters to date ... read more

New Yorker Article Weighs Sales Rep Free Speech Arguments in Off-label Context

May 22, 2014 – Both sides of the argument over whether sales representatives’ speech about off-label drug uses are protected ... read more

WLF: FDA’s Revised Reprint Draft Guidance Violates Injunction and First Amendment

May 19, 2014 – In May 15 comments to the FDA regarding its draft guidance on reprint practices for articles ... read more

FTC Cites Privacy Concerns Related to Mobile Health Apps

May 9, 2014 – Mobile health and fitness applications are on the Federal Trade Commission’s privacy-protection radar following a study ... read more

CHC Comment to FDA: Less Is More in DTC TV Ads

May 2, 2014 – The Coalition for Healthcare Communication believes that “shorter, simpler disclosures are most likely to lead to ... read more

FDA Willing to “Re-examine” Off-label Policies in Light of First Amendment Rulings

April 28, 2014 – The FDA is not taking lightly industry’s concerns that its existing off-label policies are not in ... read more

CHC Press Release: Comment on Social Media Draft Guidance

April 9, 2014 — The Coalition for Healthcare Communication issued the following press release today regarding the CHC Social Media ... read more

Some States Impose Reporting Requirements That Add to Sunshine Burden

April 7, 2014 – Although the Physician Payment Sunshine Act preempts state laws that require reporting of similar information required ... read more

Kamp to WSJ: FDA Could Do a Better Job of Defending Off-label Limits

March 31, 2014 – The FDA’s recent draft guidance on disseminating reprints, textbooks and clinical practice guidelines (CPGs) discussing off-label ... read more

OPDP Issues First Untitled Letter for Branded Facebook Page

March 14, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) on Feb. 24 issued its first enforcement letter ... read more

Cuts in Speaker Payments Should Be Placed in Proper Context

March 10, 2014 – The need for industry to educate the public on why company interaction with physicians is both ... read more

FDA Issues Updated Draft Guidance on Distributing Scientific and Medical Info on Unapproved New Uses

March 3, 2014 – The FDA announced today the availability of a new draft guidance (2014-04560) on distributing scientific and ... read more

New Tax Reform Legislation Includes Limit on Ad Tax Deductions

Feb. 27, 2014 – As expected, tax reform legislation introduced yesterday by Senate Ways and Means Committee Chairman Dave Camp ... read more

FDA Is Considering Shorter List of Risks in DTC TV Ad Major Statement

Feb. 17, 2014 – In recognition that the stream of risks currently disclosed on direct-to-consumer (DTC) television ads may be ... read more

OPDP Enforcement Letters Target Common Issues in Last Half of 2013

Feb. 4, 2014 — Many of the 14 enforcement letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP) ... read more

Caronia Decision One Year Later: Off-label Change May Be Slow, But It’s Brewing

Jan. 27, 2014 – Although FDA officials have treated the U.S. Court of Appeals for the Second Circuit decision in ... read more

Coalition Seeks Input on FDA Online Promotion Guidance

Jan. 23, 2014 – The Coalition for Healthcare Communication would like to receive feedback from its members regarding the FDA ... read more

FDA Draft Guidance Addresses Postmarket Submission of Online Promotional Material

Jan. 14, 2014 – The determining factor regarding whether a firm submits online prescription drug promotional material to the agency ... read more

Kamp on Off-label Discussion at the CMS/FDA Summit

Jan. 3, 2014 – From Coalition for Healthcare Communication Executive Director John Kamp: Several weeks ago I was privileged to ... read more

Coalition Calls on Senators to Reject Tax on Advertising

Dec. 16, 2013 – Today the Coalition for Healthcare Communication sent a letter to U.S. Senators and Members of the ... read more

House Members Speak Out Against Inclusion of Textbooks, Reprints in Sunshine Act Reporting

Nov. 26, 2013 – On Nov. 22, 23 members of the U.S. House of Representatives sent a letter to the ... read more

OPDP Sends Warning Letter Based on Statements Made on Fast Money TV Show

Nov. 11, 2013 – The FDA Office of Prescription Drug Promotion’s (OPDP’s) recent enforcement actions – four Untitled Letters and ... read more

Physician Organizations, Medical Societies Implore HHS to Reverse Policy on Reprints and Textbooks

Oct. 28, 2013 – On Monday, 33 physician organizations and 41 national and state medical societies sent a letter to ... read more

MIWG Asks FDA to Clarify Position Regarding Manufacturer Dissemination of New Use Information

Sept. 16, 2013 – The Medical Information Working Group (MIWG), a coalition of medical product manufacturers seeking to improve the ... 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.