Subscribe   RSS Contact Us

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July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ...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June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) ...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

Previous Next

Promotion Down, But Prospects Up for New Drugs

March 22, 2013 – Although spending on drug promotion has declined in recent years,  2013 could be a pivotal year for the drug industry and its marketing partners. New legislative authority has spured an already energized FDA drug approval staff to focus on novel drugs. The new program,  giving prioity for agents in critical areas,  builds on recent progress and could signal “the beginning of a new era in drug approvals,” said Coalition for Healthcare Communication Executive Director John Kamp. “Such new drugs are great for patients and give industry new reason to energize flagging marketing programs.”

Speaking March 19 at the Drug Information Association’s Medical and Scientific Communications 2013 Annual Forum held in Chandler, Ariz., Kamp told attendees that in addition to the new drug approvals program recently adopted by the FDA’s Center for Drug Evaluation and Research (CDER), the FDA Safety and Innovation Act (FDASIA) provides incentives for breakthough products and  antibiotics. These augment the biosimilar approval pathway created in the Affordable Care Act.

“It is not surprising that drug promotion rates declined in recent years as approvals slowed down,” Kamp said. “But current upward approval trends — including a recent record of 39 approvals in 2112 — combined with the CDER program to speed the approval of breakthrough products, makes it nearly certain that marketing opportunities will increase in 2013. While most of the new products are speciality products, not the blockbusters of the past, they are new products nonetheless and many will grow into substantial markets.”

But the recent numbers published by PLOS tell a different story over the past several years. The study, “Promotion of Prescription Drugs to Consumers and Providers, 2001-2010,” which was released March 4, states that a number of factors appear to have had an impact on drug promotion, which peaked in 2004 at $36.1 billion and sank to $27.7 billion by 2010. Its authors propose that those factors include a slowdown in new drug introductions, changes in the pharmaceutical pipeline, patent expiry for blockbuster drugs, and a greater number of approved biologics.

Spending on direct-to-consumer (DTC) advertising dropped from nearly $6 billion in 2006 to $4.4 billion in 2010, the study states. “During this period, television accounted for a decreasing proportion of all DTCA, declining from 62% in 2001 to 54% by 2010. Print DTCA increased 84% 2001-2006, but then declined 24% by 2010. In 2010, internet promotion accounted for less than 5% of overall consumer promotion,” according to the study summary.

“Manufacturers of branded pharmaceuticals continue to expend considerable sums on promotion to consumers and providers,” the PLOS study concludes. “However, in the context of marketplace changes, firms are decreasing spending but changing little about how expenditures are allocated across types of promotion.”

Kamp asserted that new drug development and approval initiatives will help reverse the decline in approvals that industry has seen in the past several years. For example, with FDASIA codifying accelerated approvals, innovative drugs have a better chance of being approved in a timely manner. Further, “breakthrough therapies” – those that show extraordinary clinical effectiveness – have access to “hyper fast” development, he said. And, the Generating Antibiotic Incentives Now Act (GAIN Act) provides five additional years of patent protection for qualified agents targeting priority infections.

“Add these to priority treatment for rare disease drug applications and for pediatric drugs, and the numbers surely will go up,” Kamp predicted. He also pointed out that during the past two years, FDA new drug approvals have increased from where they stood in 2010. [Editor’s note: The recent study did not tabulate spending data after 2010.]

Kamp described the new approval system – known as “The Program” – as including the following features:

  • Longer review cycles, but faster review times;
  • Better meetings, including outside consultants that will report on system
  • More late-cycle meetings to avoid “surprises” to drug sponsors;
  • Fewer, “less exciting” Advisory Committee meetings; and
  • Fewer late-cycle “complete response letters” and demands for new studies.

How all of the new approval system changes will stack up against some of the current market challenges remains to be seen, but, Kamp told DIA Forum attendees, “the greater number of approvals for new drugs that we saw in 2012 – with even more new drug approvals likely in 2013 – is most definitely an encouraging trend.”