Author: chc

Articles by: chc

CHC News

Coalition Rising Leaders Conference Helps Medical Marketers Answer Pressing Questions

Coalition Rising Leaders Conference Helps Medical Marketers Answer Pressing Questions

April 11, 2017 – There is no doubt that the Trump administration is likely to change health policy in the near future, but the questions that remain to be answered are exactly what those changes will be and how they will affect healthcare communication. For predictions and insight from an expert panel of FDA and […]

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Legislative

States Make Moves to Ease, Restrict Medical Communications

States Make Moves to Ease, Restrict Medical Communications

March 31, 2017 – With Congress in a seemingly permanent state of gridlock, individual states are taking actions that may affect how companies can communicate about their products within state borders. Arizona will soon become the first state to allow industry to communicate truthful off-label information about its products; Vermont has introduced a resolution calling […]

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Legislative

Holcombe’s E&C Testimony: PDUFA VI Will Take Patient-focused Drug Development to New Level

Holcombe’s E&C Testimony: PDUFA VI Will Take Patient-focused Drug Development to New Level

March 23, 2017 – In testimony before the House Energy and Commerce Committee’s Subcommittee on Health yesterday, Biotechnology Industry Organization Senior Vice President of Science Policy Kay Holcombe praised the success of industry user fees paid to the FDA to improve the drug review process and called on the subcommittee to reauthorize the Prescription Drug […]

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Regulatory/FDA

Gottlieb Is “Known” Entity to Pharma Industry

Gottlieb Is “Known” Entity to Pharma Industry

March 20, 2017 – Although medical marketers are very familiar with Scott Gottlieb, President Donald Trump’s choice for the top job at the FDA and a former FDA deputy commissioner for medical and scientific affairs, they can only make educated guesses about how he will run the agency of 14,000 people and what his positions […]

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Regulatory/FDA

Trump Needs to Take a Closer Look at FDA Performance

Trump Needs to Take a Closer Look at FDA Performance

March 8, 2017 – In an open letter to President Donald Trump, Pharmalot’s Ed Silverman asks that before Trump criticizes and plans any reform of the Food and Drug Administration (FDA), he should take a hard look at how the agency has performed in recent years. “During the past decade, the FDA has increasingly used […]

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CHC News

Industry Peacekeeping with President Trump Holds Promise But Portends Danger

Industry Peacekeeping with President Trump Holds Promise But Portends Danger

By John Kamp, Executive Director, Coalition for Healthcare Communication [Editor’s Note: This “The Final Word” column appeared in the February 2017 edition of MedAdNews and is reprinted with permission.] As a public official preparing for international negotiations, I was taught by the U.S. State Department to always know exactly what you want and what you’re […]

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Off-label Promotion

Citizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of the Evidence” Standard for Intended Use

Citizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of the Evidence” Standard for Intended Use

  Feb. 24, 2017 – The FDA recently published a final rule on intended use and adequate directions for use that establishes a not-previously-announced “totality of the evidence” standard and is in violation of the Administrative Procedures Act because it deprives stakeholders of fair notice and the opportunity to comment, according to a Feb. 8 […]

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Regulatory/FDA

OPDP Plans Just One Guidance Document for 2017

OPDP Plans Just One Guidance Document for 2017

Feb. 20, 2017 – Although the FDA announced last August that it would issue four advertising-related guidance documents by the end of 2016, the Office of Prescription Drug Promotion (OPDP) fell short of that goal and apparently will set a very low bar for 2017: It plans to issue only one guidance document in 2017. […]

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Washington Focus

FDA Appears Subject to Some Exemptions from Hiring Freeze

FDA Appears Subject to Some Exemptions from Hiring Freeze

Feb. 13, 2017 – A memo sent to Department of Health and Human Services (HHS) division heads last week from HHS Acting Deputy Secretary Colleen Barros attempts to better define exemptions from the federal hiring freeze imposed by President Donald Trump on Jan. 23, and may provide some relief to the FDA, which has hundreds […]

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