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July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ...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June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) ...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

July 2, 2013 – In a recent blog post on Drugwonks.com, entitled “The Ecosystem of Medical Innovation,” Peter Pitts forwarded some “solid directional guidance” from Bob Hugin, CEO of Celgene and the new Chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA).

Hugin states that medical innovation is “the crown jewel of America and its economy,” largely because research entities – companies, academic researchers, government organizations and patient organizations – have taken risks and invested in innovation.

“Bob Hugin clearly sets out how drug innovation has saved lives and improved the quality of lives around the world,” said Coalition for Healthcare Communication Executive Director John Kamp. “But innovation is directly dependent on the profits from the sale of innovative drugs, largely in America,” Kamp continued.

“Public policy experts must respect that if profits are depressed, the source of innovation will be depressed with it. Let’s all get behind Hugin and PhRMA and do a better job of retelling the basic facts of innovation to citizens and their elected leaders,” Kamp said.

The full post from Drugwonks.com is listed below:

The Ecosystem of Medical Innovation

By Peter Pitts

Solid directional guidance from Bob Hugin, CEO of Celgene and the new Chairman of PhRMA.

Supporting the ecosystem of medical innovation is the most important thing we can do to improve health care for patients with unmet medical needs in the United States.

Medical innovation is a crown jewel of America and its economy.  It has been the greatest source of longer life and economic prosperity in our country and around the world.  In the course of just one decade, from 1999 to 2008, medical innovation brought about a 45 percent reduction in deaths from cardiovascular disease.  Biopharmaceutical therapy for a devastating disease like Alzheimer’s can reduce nursing home admissions by 50 percent.  HIV has gone from an untreatable, fatal disease to a serious but manageable condition.  And in cancer, nearly 50 million life-years have been saved for patients since 1990 because of innovative approaches to cancer prevention and treatment. 

How did we accomplish this?  By working together – large and small companies, academic researchers, government agencies, and patient organizations alike.  By taking risks and investing in innovation.  And those investments have paid off in scientific advancement and economic growth. For example, the US government spent $3.8 billion over thirteen years investing in the Human Genome Project, generating enormous private sector activity.  Every $1 invested in the Human Genome Project created $140 in economic value, repaying the government for its investment via tax revenues many times over, and producing transformative scientific and medical advances for patients. 

We cannot take this ecosystem for granted.  In fact, it is very much at risk.  Short-sighted policies that limit scientific and medical innovation today could negatively affect patients for decades in the future.  Consider Alzheimer’s Disease.  The Alzheimer’s Association reports that without new disease-modifying treatments, by 2050, at least 13.5 million Americans will have developed Alzheimer’s disease, costing this country $1 trillion per year – a crushing expense.  A new therapy that delays the onset of Alzheimer’s by five years would reduce by nearly 45% the number of people with the disease by 2050, and save $447 billion per year.  We cannot afford NOT to invest in the discovery and development of such a potential treatment today. 

So how do we protect the ecosystem of medical innovation?  Fortunately, while the challenges are greater than ever, so too are the opportunities.  We are only at the early stages of being able to capitalize on the revolution in molecular biology and information technology.  With more than 5,000 new treatments in development, the promise and potential of recent scientific and technological advances is enormous.  We must be bold and courageous and stay focused on developing innovations that meet patients’ most pressing unmet needs.  And to do this, we must have a policy environment that supports  innovation, values the entire ecosystem of medical progress – academic medical centers, voluntary health associations, government agencies like the FDA, CMS and NIH, and, crucially, the biopharmaceutical company scientists, entrepreneurs and investors responsible for discovering, developing and bringing to patients the vast majority of new treatments.

Part of a supportive environment for innovation is ensuring that patients have access to the most innovative treatments. New therapies that reduce hospitalizations, promote productivity and improve quality of life have the potential to make real reductions in the overall cost of health care, but access to these treatments is critical.  Medicare Part D is an example of how the public and private sectors can work together to maximize benefit to patients and value to society.  This government supported, privately delivered program based on competition and choice has expanded access for good prescription coverage to 30 million seniors, with 90 percent satisfaction among participants, at a cost more than 40 percent lower than projections, and substantial demonstrated savings in other parts of the medical system.  We must work to protect this model and also ensure patient access to therapeutics in Medicare Part B, other government-funded health programs, and in plans offered through health exchanges.

We can improve health care in the United States by fostering a policy environment that strengthens the ecosystem of innovation, so that working together, we can pursue bold innovations that create longer life and better health for patients.