Recently in Regulation Category

You can visit Pharma Live's Med Ad News Web site to download two podcasts on healthcare issues by John Kamp, the Coalition's Executive Director.

The first is on the defeated but still looming ad tax bill.  The second is an overview and analysis of the "New FDA".

You can download them here: http://downloads.pharmalive.com/

MedAD News plans to present three more podcasts in this series.

Healthcare blogger Peter Pitts (Drug Wonks) wrote a clarifying piece, which begins:
"Much brouhaha about the DDMAC letter sent to Dr. Leslie Bauman about her, um, enthusiastic comments about a yet-to-be-approved anti-wrinkle injectable.

"At first blush this seems like regulatory creep and cause for First Amendment agita. But it isn't.  This is not a case of the FDA trying to stifle unregulated speech by an individual without "interest." Dr. Bauman is a clinical investigator for the product she's been touting. That's "interest" whether the trial sponsor paid her to do so or not. (In this instance, there was no "pay for play.") In any case, it's an unambiguous regulatory no-no."
Click to read more.  Your comments are welcome here.

The February issue of MM&M magazine spotlights Policymed.com blogger Tom Sullivan.
Read the article here:sullivan_mmandm_feb1_10.pdf

Your comments are encouraged.

Interesting discussion on why corporate backing of medical research is NOT a bad thing:

Corporate Backing for Research? Get Over It!
John Tierney in the New York Times, Jan. 25, 2010

Hyperscrutiny of Academic-Industrial Relationships: Potential for Unintended Consequences
Tom Sullivan's Policy and Medicine Blog, Jan. 27, 2010

More thoughts on the issue on Tom Sullivan's Policy and Medicine Blog

Read about it and join the discussion here.

Visit the Health Central Web site for more information and resources for participation in the process:
Health Central

The American Association of Advertising Agencies and the Coalition for Healthcare Communication have formed a working group to help the FDA create its new Internet and Social Media rule. 

For background information, read:
Fabio Gratton's Ignite Blog
Mark Marmur's December 10th Presentation - Update on the FDA's Social Media Hearings
Marmur-FDASMUpdate_Dec10_09.pdf
and visit the Coalition's Overview page

In one of her final acts as NJ Attorney General, Anne Milgram's office has issued a new report, "Physician Compensation Arrangements," recommending limitations to physician-industry relationships for state agencies that go above and beyond guidelines outlined by PhRMA and other organizations.

Although this proposal comes from the office of the outgoing Attorney General, and would be an unlikely top priority for the Christie Administration, many of the recommendations could be implemented in the Garden State without legislation. Recommendations that could soon be implemented include:

• Banning all food, entertainment, etc., paid for by industry, going above and beyond the PhRMA guidelines
• Requirement that doctors report financial compensation of $200 or more from the pharmaceutical industry over the past two years
• Require 25% of physician CME be obtained from evidence-based educational programs or academic detailing (government controlled CME)
• Directive that the NJ Legislature limit commercial use of prescriber data, similar to requirements enacted in New Hampshire and other states

To read a detailed outline and the full report, click here. 

Coalition Statement - DTC Advertising

Recent news coverage regarding a Harvard Medical School study showing correlation between Plavix price increases for Medicaid programs in 27 states and direct-to-consumer advertising costs is unfounded. As study authors concluded, DTC advertising was not associated with an increase in Plavix use above preexisting trends.  Additionally, Medicaid pharmacy expenditures increased substantially only after the initiation of DTC advertising because of an increase in the cost per unit.  These findings prove nothing about DTC advertising value for patients, or even the relationship between DTC advertising and product pricing.

DTC plays a critical role in informing patients about their treatment choices, and as the starting point in a dialogue between physician and patient in defining a treatment path. The Coalition supports responsible, effective communication on treatment benefits and risks that improve physician-patient dialogue and foster better care. Limiting FDA-vetted healthcare information impedes access to fair-balance information and stunts two-way dialogue between a patient and their doctor critical to improving medical treatment and quality-of-life.

Highlights, commentary and analysis of the November 12th and 13th testimony at the FDA's Public Hearing on the Internet and Social Media:

Coalition Message on Social Media Hearings
By John Kamp, Executive Director
Analysis of the issues

Paper on FDA Public Hearing on the Internet and Social Media
By Peter Pitts, Center for Medicine in the Public Interest
Documentation, timeline, analysis

Highlights of FDA Public Hearing on the Internet and Social Media
By Mark Marmur, Markovsky + Company
Summary of each item of testimony for both days

Click to view.



Comments are invited.

In his Drug Wonks blog, Peter Pitts wrote the following overview of Day 2 of the FDA hearing on social media. He highlighted the diverse views and concerns of witnesses on the subject of "adverse event" reporting and publicity.

    "Adverse event generation is the real bête noire of social media.

    "Should companies actively avoid participation - even to the degree of monitoring - lest they uncover an adverse experience?  Shouldn't companies embrace social media so that adverse experiences can be found with greater alacrity?  Shouldn't companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it's not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.

    I know of one large pharmaceutical company whose policy is not to monitor social media sites because they don't want to unearth adverse events.  Is this responsible?  Is it even supportable?  If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn't look good on Page One or sound very good in front of a congressional subcommittee.  "In compliance" and "in the best interest of the public health" must not be mutually exclusive propositions."

Read the rest of Friday's summary on DrugWonks.com.   We want to hear your comments here.