Parker Waichman LLP

Medical Device, Drug Makers Seek to Head Off Regulation by Disclosing CME Grants

  Drug Makers Facing Scrutiny From Congress. Medical device makers and drug companies, facing increasing scrutiny from Congress, have decided to come clean about donations and grants they provide to fund medical education programs, patient advocacy organizations and other groups. Drug maker Eli Lilly already has such a program, and, Medtronic Inc., a maker of among other things, […]

Drug Makers

 

Drug Makers Facing Scrutiny From Congress. Medical device makers and drug companies, facing increasing scrutiny from Congress, have decided to come clean about donations and grants they provide to fund medical education programs, patient advocacy organizations and other groups. Drug maker Eli Lilly already has such a program, and, Medtronic Inc., a maker of among other things, implantable defibrillators and defibrillator components, has announced it will disclose such funding on its website starting May 1. Other drug and  medical device makers recently told one lawmaker they intend to start similar disclosure programs. While some patient advocates have praised such plans, others fear that the proposed disclosure efforts are simply an attempt by drug and device makers to end a push in Congress towards legislation that would require public disclosure of their giving.

The move to be more forthcoming about funding efforts comes on the heels of a letter written in February by Sen. Charles Grassley (R-Iowa)  to 15 of the nation’s biggest drug and device companies. Grassley asked if the companies planned to start publishing grant information on their websites, in the way Eli Lilly began last year.  Grassley, a member of the Senate Finance Committee, said he was particularly interested in grants the companies used to fund Continuing Medical Education (CME) programs for physicians.

Physicians must attend CME conferences in order to keep their licenses

Physicians must attend CME conferences in order to keep their licenses, and many drug and medical device makers “generously” fund such events. In fact, in 2006, pharmaceutical companies alone spent over $1 billion on CME courses. Unfortunately many of these courses are thinly disguised marketing ploys. Last summer, a Finance Committee found that drug companies were actually using CMEs to influence clinical practice guidelines and Medicaid formularies.

The Accreditation Council for Continuing Medical Education (ACCME) has rules spelling out who is allowed to pay for CME courses, and drug companies and device makers are not allowed to directly fund such programs. But “directly” is the operative word here. There is nothing in the rules that prohibits the manufacturers from paying a third party to design and promote courses. And that’s exactly what they do. Very often, the course materials designed by consultants for these programs exaggerate the benefits of the sponsoring company’s products, and downplay side effects and other safety issues. And it is not unusual for these conferences to include information on off-label uses of drugs and devices, something which manufacturers are legally barred from doing directly.

Congress has recently been threatening to legislate disclosure requirements for drug and device makers

Congress has recently been threatening to legislate disclosure requirements for drug and device makers.  In his February letter, Grassley wrote, “If your company does not yet have any efforts or plans in place, please explain why not.” The answers have been  positive, with most agreeing to disclose CME funding, and many volunteering to publicize payments to patient advocacy groups such as the American Heart Association. In addition to Medtronic, AstraZeneca has plans to start posting its funding efforts to its website by August 1. Merck, Amgen and Abbot Labs all said they are working on developing plans to disclose funding programs,. Only Schering-Plough rebuffed Senator Grassley, saying “We do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us.”

While Grassley said he was happy with the results of his letter writing campaign, others were more cautions. Dr. Peter Lurie of the consumer group Public Citizen told the Associated Press that drug and device makers’ voluntary disclosure efforts could be little more than an effort to ward off legislation that would require more comprehensive disclosure.  “If they were doing this out of the goodness of their heart, they would have done so decades ago,” Lurie said.

Need Legal Help Regarding Drug Makers?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Wow I have never had such a positive review of a law firm and I guess it’s because they never get it all right. This law firm did and they were the ultimate in professional acumen, business acumen and they made what I thought would be a hard process very easy. Tina Morace was the ultimate para legal who when I called and or had a question if was in a call,on vacation or busy made sure to make me a priority and return all my calls within half hr. Service like this makes me and will make me always recommend this law firm and to feel comfortable doing so. Tina’s service I hope will be recognized as she is the ultimate professional and made me feel comfortable for the whole two year process. Have an awesome day and once again they are awesome.
Cleveland Bannister
3 years ago
5 Star Reviews 150
I wanted to give huuuuugeee props to my Medical Coordinator, Joanne. She is professional, sweet, dedicated and committed to listening, comforting, and guiding me through this journey.
SooSweet NY
6 months ago
5 Star Reviews 150
the team of Parker Wachman (Josephine Burgess-Zephrine and Juno} showed courteous attention to my needs as my case is pending, it is not often one can find the dedication this team has shown in providing a client with the hands on attention that is needed in turmoil times involving a personal injury
steven grant
5 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038