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Kamp: 2014 Election Results Will Have Impact on Medical Marketing

Nov. 14, 2014 – Tax reform, privacy legislation, Sunshine Act implementation and FDA/HHS enforcement and emerging policies all are issues ... read more

CMS Reinterprets Sunshine Act Final Rule to Exclude Certified CME Costs from Reporting

Nov. 3, 2014 – The certified continuing medical educations (CME) community got a “treat” on Oct. 31, when the Centers ... read more

The Elections Are Over: What Does It Mean for Healthcare?

Oct. 28, 2014 — Join us for a Webinar on Nov. 12! John Kamp, Executive Director of the Coalition for ... read more

FDA Response to MIWG Shows Willingness to Revisit Off-label Speech Policies

Oct. 27, 2014 – As members of Congress prepare legislation that may establish the conditions under which companies can share ... read more

House Legislation to Tackle Thorny Off-label Issues

Oct. 20, 2014 – It is looking like Congress may attempt to settle whether companies can speak truthfully about their ... read more

Bipartisan Bill Seeks Fix to Formalize Textbook/Reprint Sunshine Act Exclusions

Oct. 14, 2014 – After multiple efforts failed to convince the Centers for Medicare & Medicaid Services (CMS) that peer-reviewed ... read more

PhRMA, BIO, AdvaMed Tell FDA Social Media Guidance Is Lacking, Violates First Amendment

Oct. 6, 2104 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) recently reopened the comment period for its ... read more

Social Media Master Class Helps Companies Navigate Compliance

Sept. 30, 2014 – Companies striving to use social media marketing both effectively and appropriately likely will benefit from a ... read more

Coalition Panel: Data Regulation Focus Shifting from Privacy to Security

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In Amicus Brief, PhRMA Says Off-label Case “Raises Serious First Amendment Concerns”

Sept. 19, 2014 – Stating that a whistleblower’s interpretation of the False Claims Act has “a critical flaw” because it ... read more

Pfizer’s Susman to Talk Public/Private Partnerships at Nov. 10 Coalition Briefing

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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

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

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

House Committee Seeks Patient Input on Availability of Treatments

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FDA To Study Viewers’ Responses to DTC Ad Risk Information

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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

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

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

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Coalition Calls on Senators to Reject Tax on Advertising

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

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Proposed OTC Drug Distribution Would Expand Patient Access to "Rx" Drugs

April 30, 2012 – Comments are due May 7 on an FDA-proposed paradigm that would allow the agency to approve

certain drugs – that would otherwise require a prescription – for over-the-counter (OTC) distribution under “conditions of safe use.”

An FDA statement regarding expansion of the definition of nonprescription drugs says that the agency believes that some doctor visits can be eliminated under the new paradigm to remove cost or time barriers that may deter consumers from receiving appropriate medications.

“We applaud the FDA for jump-starting a public conversation about how to get medicines into the hands of people who need them with adequate directions for safe and effective use,” said Coalition for Healthcare Communication Executive Director John Kamp. “Public and targeted communication will be key to success. The stakes are high because success here means better health for individuals and better public health outcomes.”

According to Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, OTC drugs have had great success in providing consumers with excellent self-care options. “But viagra online in spain our concept of self-care is limited to conditions that can be self-diagnosed and self-treated based on the information in the drug facts box, combined with common knowledge. What we are asking is, should there be more flexibility in the concept of nonprescription drugs? Can we broaden the assistance a consumer gets and increase the types of medicines that might be available over-the-counter?”

The new paradigm would ensure safe and appropriate use by applying special conditions to types of nonprescription products. “For example, before getting a medication, you might have to talk with a pharmacist, or need to have a diagnostic test,” the FDA states. “In other cases, you might have to visit a physician to obtain the original prescription, but not to get refills. FDA is also considering whether some drugs could be a prescription drug and a nonprescription drug with conditions of safe use.”

Among many questions cited in a call for comment published in the Feb. 28 Federal Register, the agency has requested input on the feasibility of this initiative, and what types of evidence would be needed to demonstrate that certain drugs could be used safely and effectively in an OTC setting. The agency also has requested input on dual availability of drugs by prescription and OTC and whether diagnostic tests would need to validated for a change in setting, such as in a pharmacy.

The agency lists a number of potential benefits for consumers from this initiative: an increase in the appropriate use of medication, decreases in health costs, greater access to health screening, easier access to needed medications, and better, more consistent treatment of common conditions. Major challenges with the proposed paradigm shift include reworking FDA rules and separating patients from appropriate medical care. Other potential challenges are: liability concerns, disruption of workflow for often overburdened pharmacists, equipment costs, and questions about health insurance reimbursement.

Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, said on DrugWonks.com that some questions still remain regarding this proposal, such as: “How will this impact patient compliance?  How will this affect one condition masking another, more serious one? How will this change the role of the pharmacist?”

“Hopefully stakeholders will share their views on this proposal so the FDA has the information it needs to consider this option,” Kamp said. “Regardless of the outcome here, FDA is to be commended for thinking outside of the box.”

User Comments 3

  1. This is a wonderful idea. So many times, if you are ill and you know what it is going to take to treat, it would save so much time in treatment; whereas if you TRY to make a doctor’s appt, it may be 3-5 days of misery before your appt. Personally, my family goes to Mexico for various meds such as heart medicine, gastric medicines, migraine, and antibiotics. Since the individual is the dispenser, we tend to be much more careful and do our research before taking the meds.
    I think this should be implemented!

    Marilyn Pittman on May 4, 2012 @ 4:56PM
  2. Consumers have become much more savvy over the years. The Internet offers information and many people successfully self diagnose and treat daily. Additionally, those that do not have health insurance (and those that do) can feel confident that they will have a choice to take care of themselves without expensive MD visits. ER visits and hospitalizations will decrease for minor ailments as people have access to previous prescriptive only medications and realize that they are responsible for their own health and wellness. This initiative will increase consumer driven health and wellness. Being responsible for your health and knowing you are personally accountable will most likely lead to healthier citizens. This out of the box thinking is what we need. Freedom of choice and accountability and responsibility for self care is paramount.

    Sandy on May 6, 2012 @ 5:14PM