Policy and Medicine

CBI’s 8th Forum on Educational Grants

 
This fall, the Center for Business Intelligence (CBI) will be holding its 8^th Forum on Educational Grants on September 14-15, 2010 in Philadelphia, PA, at the Doubletree Hotel.

The forum provides an opportunity to discuss the challenges surrounding commercial support for medical education programs, and will be led by more than 20 continuing medical education (CME) experts from supporter and provider organizations.

These individuals and leaders in CME will use the forum to discuss ways to overcome challenges and maintain compliance in the funding of educational programs that attain high-level outcomes.  Topics to be explored on the agenda include:

• Development of a clear, concise CME value proposition
• Examination of transparency measures and compliant reporting of grant funding
• Considerations for grant reconciliation
• CME cost containment   

From these topics, participants will see a much more in depth look at a timeline of important events affecting CME from 2009 to present, as well as:

• Discuss the key elements of the Patient Protection and Affordable Care (PPAC) Act including the Physician Payments Sunshine provision;
• Explore the key players and departments within HHS impacting PPAC; and
• Examine state statutes

In addition, panel members will:

-    Review current obligations/requirements for public reports;

-    Review various company styles/report elements; and

-    Evaluate the potential elements of a report from all the stakeholder perspectives

 

Among numerous other topic areas, the forum will also look at ways to mitigate risks and maintain compliance throughout the funding process by exploring why the government is really so suspicious about CME, and learning what CME providers can do to navigate compliance landmines.        

For more information or to register, click here.

Medical Meetings: Coffee a Conflict of Interest?

The American Society of Clinical Oncology (ASCO) recently held its annual meeting in Chicago, Illinois. The conference underscored how “new limits on free gifts to doctors have hit the ubiquitous free lattes and coffee seen at major medical meetings,” according to MSNBC.

While “the conference exhibit floor still featured massive information booths from cancer drugmakers like Roche Holding AG , Bristol-Myers Squibb Co and Amgen, Inc., the days of shopping bags laden with pricey goodies are long gone.” Some companies are still offering “coffee or candy with no strings attached.” For Pfizer, Inc. however, they require doctors to swipe their registration cards and warn that physicians from Minnesota and Vermont are prohibited from imbibing.” Pfizer also warns in a sign in front of the coffee machine that it may provide the names of coffee-drinking doctors to regulators.

With regards to international doctors, “exhibit booths at ASCO also have to strictly separate medical information given out, under guidelines set by the U.S. Food and Drug Administration, which can also mean coffee only for doctors with foreign ID badges.”

Such policies are unnecessary considering “many companies said they would stop giving out small gifts such as pens and flash drives as part of new voluntary guidelines from the Pharmaceutical Research and Manufacturers of America (PhRMA). The trade group has also banned more costly gifts like trips to resorts, and called for companies that pay for medical education at conferences to leave the content to outside experts since 2002.

As a result, the kind of practices seen at ASCO is “absurd,” according to Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, because there is no way these restrictions will “solve the issue of healthcare in this country.” We need to be encouraging and enticing doctors to attend these voluntary events because they will benefit patients and society tremendously. For doctors who use their nights and weekends, while paying for hotel rooms, travel, and other expenses, a cup of coffee to keep a busy day going is the least a conference can do. And it’s not like many Americans have a problem with that.

For example, a recent poll showed that almost 80% of people felt that a cup of coffee wasn't going to influence a doctor to prescribe a certain medication. Clearly then, the growing concern that undisclosed financial ties, such as cups of coffee or meals, have lead to increases in healthcare costs is misguided to say the least.

These events are crucial for doctors to share experience, data and knowledge with their peers to help establish networks that can collaborate in ways to help patients in particular disease areas.

If critics have such a problem with free coffee, perhaps doctors who attend these conferences should have their patients bring them a cup. Surely, any patient who understood the impact such events have in the future abilities of their doctor to treat and diagnosis their disease, they would gladly pay for a lifetime of coffee if it meant a lifetime they had to live.  

 

Conferences: Fourth Annual FDA Regulatory Symposium

The Fourth Annual Regulatory Symposium, Sept. 30-Oct. 2, 2009, in Washington, D.C., is only two days away and the entire event can is accessible both onsite and online.

 

The Symposium features a Who's Who of FDA's new leadership, including FDA Commissioner Margaret Hamburg, CDER Director Janet Woodcock, CDER Associate Director for Medical Policy Robert Temple, along with an array of other agency officials on the key regulatory issues facing drug and device companies. The agency's key decision makers will be joined by numerous industry thought leaders and outside experts to address the agency's regulatory and enforcement priorities. To review the entire agenda, visit: www.fdasymposium.com.

 

Topics covered in this FDA regulatory event include:

• FDA's Regulatory Agenda: Margaret Hamburg, FDA Commissioner
• Comparative Effectiveness: Robert Temple, CDER, FDA
• FDA's Safe Use Initiative: Janet Woodcock, CDER, FDA
• FDA Enforcement: Tom Abrams, CDER, FDA
• FDA's Device Approval and Safety Initiatives: Jonathan Sackner Bernstein, MD, CDRH, FDA
• The Agency's Approach to Social Media: Sanjay Koyani, FDA

In addition, five former FDA Chief Counsel to will address Off-Label Promotion, Enforcement, Preemption, and other key issues.

 

Also, industry thought leaders and outside experts will address the latest developments in Enforcement, Drug Safety, Risk Management and Social Media.

 

Conference Co-Chair Peter Pitts, the President of the Center for Medicine in the Public Interest, will steer the discussion on Day One and join other industry experts in assessing the industry's latest efforts related to managing conflicts of interest as part of a special panel discussion.

 

Date: Wednesday, Sept. 30 - Friday, Oct. 2, 2009

 

Location
Renaissance Washington DC Hotel
999 9th Street, N.W.
Washington DC 20001

 

Via the Web

The entire event can be accessed from the convenience of your office by visiting: www.fdasymposium.com/registration.html

 

For more details please visit www.fdasymposium.com

 

Health Care Convention and Exhibitors Association Annual Meeting

For those readers who follow closely health care conventions and the rules around exhibits, the Health Care Convention and Exhibitors Association is holding their annual meeting June 13 – 16 at the Tampa Convention Center in Tampa Florida. Because of the changes to the education and conventions industry they have added several sessions on compliance with the PhRMA code, state and federal laws.

For more Information:  Health Care Convention and Exhibitors Association Annual Meeting