Subscribe   RSS Contact Us

FDA Will Study How Market Claims, Efficacy Info Affect Consumers in DTC Drug Print Ads

July 29, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) recently announced that it plans to conduct a ... read more

Congressional Briefing: Medical Information Communication Is Important Patient Issue

July 28, 2015 – Physicians and their patients need access to truthful and non-misleading data about available treatments, including off-label ... read more

CME Update: CMS Revises Guidance and Industry Ups Spending

July 20, 2015 – Two recent developments in the continuing medical education (CME) arena – a revision to CME guidance ... read more

Kamp: 21st Century Cures Act and Amarin Case Developments Are Signs of Progress

July 13, 2015 –Two events last week – the House approval of the 21st Century Cures legislation and arguments in ... read more

House Approves 21st Century Cures Act, Bill Now Heads to the Senate

July 10, 2015 — The House of Representatives today passed H.R. 6, also known as the 21st Century Cures Act, ... read more

21st Century Cures Legislation Garners House Majority Support

July 1, 2015 – The 21st Century Cures Act, which was unanimously approved by the House Energy and Commerce Committee ... read more

Google SEM Changes Affect Drug Black Box Reminder-like, Redirecting Ads

June 29, 2015 – Two changes to search engine marketing (SEM) recently announced by Google could soon alter how pharmaceutical ... read more

OPDP Sends Six Enforcement Letters in Six Months

June 23, 2015 – The Office of Prescription Drug Promotion (OPDP) sent just six Untitled Letters to industry for alleged ... read more

Physicians Say CHC-backed H.R. 293 Would Remedy “Burdensome” Sunshine Act Reporting

June 15, 2015 – More than 100 physician organizations have written to Rep. Michael Burgess (R-TX) to express their strong ... read more

Author of “Pharmaphobia” Says Conflict-of-interest Regulations Are Slowing Medical Progress

June 8, 2015 – In his new book, “Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation,” Tom ... read more

New House Bill Would Enable Links in Internet and Social Media

May 27, 2015 — On the heels of the swift approval last week of the 21st Century Cures Act in ... read more

House Energy and Commerce Committee Wholeheartedly Approves 21st Century Cures Act

May 21, 2015 – In a unanimous (51-0) vote today, the House Energy and Commerce Committee approved the 21st Century ... read more

21st Century Cures Legislation Poised for Full House Committee Vote This Week

May 18, 2015 – Major medical legislation, including closely followed provisions on off-label communication and Sunshine reporting, survived a House ... read more

FDA Plans for Off-label Communication Draft Guidance, Meeting

May 11, 2015 – With off-label provisions in the 21st Century Cures legislation in the works and the courts bearing ... read more

FTC to Industry: Consumer Health Data Subject to Privacy, Security Protections

May 4, 2015 – The Federal Trade Commission (FTC) has issued a reminder to industry members collecting, using or sharing ... read more

PhRMA Authors Call for FDA to Establish Off-label Communication Safe Harbor

April 27, 2015 – Because “sharing more information rather than less” about the off-label uses of approved drugs “is critical ... read more

FDA Draft Guidance Describes Framework for Electronic Submission of Promotional Materials

April 22, 2015 – Healthcare marketers soon will have to submit promotional labeling and advertising materials to the FDA electronically, ... read more

Changing of the Guard at PhRMA

April 20, 2015 – The Pharmaceutical Research and Manufacturers of America (PhRMA) last week announced changes to its board – ... read more

Coalition to Sponsor Medical Marketing Pitch Webinar

April 6, 2015 – The Coalition for Healthcare Communication is sponsoring a Webinar May 6 that will highlight both basic ... read more

2014 DTC Ad Spending on the Rise

March 25, 2015 – The amount of money that drug companies spent on direct-to-consumer advertising rose from $3.8 billion in ... read more

What Does OPDP’s Enforcement Lull Mean?

March 12, 2015 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued fewer enforcement letters in recent years, ... read more

Who Says You Can’t Fight City Hall?

Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director March 9, 2015 – I am not sure ... read more

DAA Expands Ad Privacy Controls to Mobile Marketplace

Feb. 26, 2015 – To “bolster both consumer trust and marketplace growth,” the Digital Advertising Alliance (DAA) yesterday launched two ... read more

Leveraging Technology and Other Highlights from DIA Marketing Meeting

Feb. 23, 2015 – Dale Cooke, owner of PhillyCooke Consulting, who spoke Feb. 18 at the Drug Information Association’s Marketing ... read more

FDA Budget Increase Relies on Higher User Fees

Feb. 16, 2015 – Although President Obama’s proposed budget for fiscal year 2016 includes increases for both the FDA and ... read more

Revised Guidance on Use of Brief Summary in Print DTC Ads: Full PI Is Not Needed or “Recommended”

Feb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version ... read more

FDA Commissioner Hamburg to Leave FDA

Feb. 5, 2015 – After serving the FDA for six years, Commissioner of Food and Drugs Margaret Hamburg, M.D., will ... read more

21st Century Cures Discussion Draft Includes Textbook/Reprint Language, Communication Fixes

Jan. 29, 2015 – A 393-page discussion draft of legislation designed to accelerate the 21st Century Cures initiative – released ... read more

Transparency Proponents Slam Company-Provider Communication

Jan. 26, 2015 – Although biomedical companies can legally communicate and share information with physicians under the Physician Payments Sunshine ... read more

FDA Moves Forward with Major Statement Study, Responds to Coalition’s Comments

Jan. 14, 2015 – The FDA is taking the next step toward examining whether shorter, simpler risk disclosures in direct-to-consumer ... read more

Coalition: Issues to Watch in 2015

Jan. 13, 2015 — As 2015 gets fully underway, there are several issues that healthcare marketers should be following, according ... read more

Kamp to WSJ’s Pharmalot: CMS Move on CME “One of Biggest Flip Flops” Ever

Dec. 18, 2014 – This week’s release by the Centers for Medicare & Medicaid Services (CMS) of subregulatory guidance on ... read more

MM&M Tax Reform Prognosis: Stay Tuned

Dec. 4, 2014 — The looming threat of eliminating the marketing tax deduction as part of overall tax reform may ... read more

Previous Next

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