Last week, the Maryland House of Delegates Government Operations Subcommittee held a hearing on HB 818, known as the Manufacturers of Prescribed Products – Payments to Health Care Professionals – Prohibition. As introduced, the purpose of the legislation is to prohibit a manufacturer of prescribed products from offering or giving a gift to a health care professional. We previously provided a summary and analysis of the bill.
Consequently, at the hearing, the overwhelming majority of members from the public spoke against the legislation. Below is a list of those who testified on HB 818, including a brief summary of their testimony. To view the hearing on HB 818 click here. Testimony begins at 5:18:22, that is right 5 hours and 18 minutes into the hearing.
Testimony
Maryland Delegate Nicholaus Kipke (R-Anne Arundel County)
Mr. Kipke, the sponsor and author of the bill, spoke in favor of the legislation. He called for the creation of a strong firewall because prescription drug use in Maryland has increased over the past 10 years. Of course, he failed to realize that healthcare and patient outcomes, life expectancy, and treatments of other disease have significantly improved for Maryland patients over that time as well.
His testimony focused on the incident at St. Joseph’s hospital, which was his clear motivation for the legislation. He talked about thought leaders and consultants who go out and talk to doctors over meals. He chided industry codes for them being voluntary.
Consequently, Mr. Kipke was asked what the difference between politicians getting payments from industry in the form of political contributions to candidates and doctors receiving “gifts” or payments for services. He struggled to find how there was an ethical difference in these kind of payments. Mentioned that there was rules by members of legislature. He also struggled to answer whether HB 818 will slow down access of physicians to information from companies. He did however admit, that HB 818 will most likely slow down access.
Delora Sanchez, Nicki McCann, and Julie Gottlieb – Johns Hopkins
John Hopkins offered its support of HB 818 but with specified amendments, which they provided to the committee. The panel talked said JHU’s 2009 policy on interactions with industry was similar to HB 818, but emphasized that HB 818 must ensure appropriate interactions between industry-physician, including education.
The amendments offered focused on the fact that accredited continuing medical education (CME) has adequate oversight, and that there is a need to modify the provision in HB 818 that calls for more than one presenter. The panel also recognized that industry support of CME is welcomed and necessary and not an issue because accredited providers adhere to strict standards of commercial support, which prohibit marketing and promoting products.
Moreover, JHU asserted its concerns that HB 818 could be interpreted so broadly to eliminate HCPs taking part in these activities to recommend treatments. This is problematic because doctors need to be able to educate physicians that a given disease can be treated with a specific class of medicine that is supported by evidence, and practice. JHU also emphasized the need to allow training for devices, and noted that a written agreement should be with the institution who purchases the devices, not the HCP.
Wendy Kronmiller – Assistant Secretary Regulatory Affairs/Maryland Division of Regulatory Affairs, Department of Health and Mental Hygiene
MDMH supported the bill because of concerns about overutilization and overpayments of drugs and patient harm. They clarified that they did not want to thwart medical progress by enacting HB 818 and put Maryland behind other states in conferences and medical events. The testimony clarified that the Sunshine Act in the Affordable Care Act is only a disclosure registry, rather than a ban, and they were not sure whether this would be good enough for Maryland, since consumers may not use it.
Howard Fienberg – Marketing Research Associates (FWA)
Marketing Research Associates supported HB 818 with an amendment that the legislation excludes survey research because there needs to be incentives to encourage people to participate in bona fide surveys. He noted that marketing research, doesn’t influence participants or get them to do something.
Dan Bellingham – HDMA Health Distribution Management Association
Noted that there are 12 companies that operate in MD, and that the association opposes the bill because of its inclusion of wholesalers. He clarified that wholesalers only take the product from producer to hospital, pharmacy, office, etc. Wholesalers don’t push one product over another. No marketing on products, only services, in wholesaling. He recognized that in Minnesota, Massachusetts, Vermont, and the Sunshine Act, wholesalers were specifically excluded.
Jay Schwartz – MedChi (opposed/amendments)
MedChi was opposed to the bill, and emphasized that the bill was poorly written and sloppy. MedChi noted that the legislation would negatively impact accredited CME by preventing meals. Mr. Schwartz noted the hypocrisy in this portion since government meetings sponsored by pharmaceutical companies could have such meals. In addition, he emphasized the positive value pharmaceutical companies provides to hundreds of thousands of medical programs in Maryland that doctors participate in. He gave the example of an ophthalmology program, supported by industry, that examined delegates and their staff in the capitol just a few weeks before the hearing. In the end, he emphasized that there should not be a ban on giving education and industry support to groups, because these are good programs. He asked the committee to look at MedChi’s guidelines on gifts to physicians, that were approved in 1992. He acknowledged that these physician-industry relations are extremely complicated, and a more nuanced approach similar to the 8 page policy from AMA is necessary.
Michael Altus
Mr. Altus, a medical writer, supported the bill because through his experience working for pharma, his concerns and experience about ghostwriting caused him to worry about gifts. He emphasized the fact that companies have their own policies about employees giving and receiving gifts, and that there is no such thing as a “free lunch.”
Marta Harding – AdvaMed
On behalf of AdvaMed, Ms. Harding noted that 25 members of AdvaMed are based in Maryland, and three attended and testified at the hearing. She noted how these companies have thousands of employees in the state. While AdvaMed understands and shares the concerns of bill, Ms. Harding noted that AdvaMed has taken aggressive steps to address to address these issues, including a strict and aggressive code of conduct. Accordingly, she asserted that HB 818 will have negative unintended consequences that will stifle appropriate interactions with doctors and industry, which promote innovation and patient safety.
Chris White – General Counsel for AdvaMed
Mr. White discussed his leadership in helping create the AdvaMed Code of Ethics. He noted how devices demand close physician-industry interaction and that most companies are small, with 50 employees or less, but that many of these bring many breakthrough technologies. He discussed one example, an orthopedic hip, which is highly personalized and requires over 300 instruments. He noted that these devices are supported by physician intervention and collaboration, and that devices serve as an extension of a surgeons hands. As a result, he acknowledged that a highly interactive relationship between physicians and industry is what fuels ongoing advances in medical technology and that training physicians on to use these devices is critical for patients safety
He also noted that HB 818 is negative because it would prohibit demonstration devices, which allow doctors to show patients what treatment/device they would get. Finally, he also emphasized that the Sunshine Act and anti-kickback statutes are sufficient to address the concerns of HB 818.
Kevin Tibido – Vapotherm
Speaking on behalf of a small company, Mr. Tibido’s testimony focused on the administrative burden of complying with HB 818. He too recognized that the AdvaMed Code and federal regulations are adequate. He discussed how his company makes a respiratory device that replaces more complex/expensive technologies. Staff of his company go into offices and hospital and meet with physicians, nurses, and therapists, to make sure they broadly know how their technology works, how to save patients from more evasive procedures, and how to operate the devices safely. Finally, he recognized that meals provided for these training sessions are not unethical because often, HCPs have no time other than lunch to be educated.
Richard Hewitt – VP of CSI Medical
Also from a small medical company in its early stage with 20 employees, Mr. Hewitt discussed his company’s approved device that helps treat cancer. The device is FDA approve and has been used in over 6,000 treatments, in over 80 AMCs, and has been written about in 15 articles in 9 peer reviewed journals. Now that the product has taken off, his company wants to grow and add employees and tax base in Maryland, but he noted that the key thing to growth is robust physician interaction during testing, development. Without high frequency interaction with nurses andphysicians, he noted that his company would fail. And he clarified that these interactions were luxurious or glamorous, but rather coffee and bad food purchased not to induce, but to stay alive.
He recognized that devices help fill unmet needs of patients and that doctors need much more training for medical devices. He noted that a problem with HB 818 is that it would prohibit a company from having a researcher in surgery because it would only be one educator from one company. Without this training, someone would be hurt or die. Accordingly, he stated that Maryland needs to remain competitive to attract genius and capital, and should be making business easier not harder.
Michael Radford – WL Gore and Associates
Mr. Radford echoed concerns about HB 818, and noted that his company’s 23 plants and 2300 employees would be impacted because of the costs and administrative burdens to implement the legislation. He emphasized the importance of device companies interacting with doctors for initial development, training and feedback.
Renee Wensky – CEO Tech Council of Maryland
Representing the biotechnology trade association, Ms. Wensky opposed HB 818 because it is unnecessary, duplicative, and will harm Maryland as a leader in innovation/medicine. She noted how BIO already has a wide array of regulations and agencies overseeing its ethical concrerns, and that HB 818 will just add more regulation and infrastructure cost with little return. It would also put small companies at a competitive disadvantage, and will restrict their ability to research. She also noted that HB 818 would make it difficult for Maryland to attract and retain companies.
John Murphy – BIO
BIO oppose the bill and echoed Ms. Wensky’s comments, noting that small companies will be impacted most directly because compliance costs are difficult to overcome for small companies, and such legislation is unnecessary because these companies already deal with federal regulations.
Tom Sullivan – Rockpointe, Inc. 6:23:40
I talked about the impact HB 818 will have on CME in Maryland. I discussed a wounded warrior program that my company produced, where physicians were educated to treat pain from soldiers, that would be prohibited because it was supported by industry.
I emphasized that HB 818 will jeopardizes patient care by having a chilling effect on the necessary exchange of new treatments, including FDA mandated education. I also noted that the bill would imperil medical education/training and that hospitals and institutions will discontinue CME programs to avoid violating the law. This will kill the market for CME programs, especially when meals would not be allowed. I echoed others in noting that HB 818 is also duplicative because of existing federal laws, such as AMA, ACCME, HHS OIG.
A family practitioners, who is the director of treatment for methadone clinic echoed my comments, and noted the importance of CME events to gain intelligence and improve care for patients. He noted how CME programs supported by industry are crucial because it allows him to interact with colleagues, ask questions, ask speakers how to treat problem patients, and permits 1 on 1 dialogues with speakers and peers.
Lee Gresser, MD, Medical Director Methadone Clinic
Dr. Gresser former President of the Maryland Association of Family Physicians noted that the intent may be good but his concern is the bills negitive effect on continuing medical education. He was surprised at the Hopkins support given their collaboration on events such as PriMed. He loves the interaction with colleagues and with speakers on important issues provided in dinner meetings. Brought up that physicians have discernment and discussed the high integrity of the pharma and device companies. There are 27,000 physicians in Maryland and only one ran into trouble, wants proactive not re-active legislation.
Patty Camorrata
Ms. Camorrata has 12 years working in CME, and noted how CME providers collaborate with universities, societies, and other groups to look at disease state. Then, they conduct literature research, talk to leaders in areas, and create education plans based on research. She noted how CME improves performance and providers are very involved in metrics and measuring learning to identify gaps in education. She noted that learning requires repetitive activities and that if it does not happen, learning goes back to base level. She concluded by noting that if Maryland gives up local/regional meetings, we will give up repetitive opportunity for learning, which will directly impact patients in Maryland.
Marjorie Powell –PhRMA
Ms. Powell noted how 20 companies in Maryland are working on rare diseases that affect 200,000 people or less. She noted that these 20 companies in Maryland are doing research or have an application at FDA to market a treatment for one or more rare diseases. Consequently, under HB 818, if they wanted to hire professor from JHU to talk to researchers about the research that that academic physician did on a rare disease to help provide background on disease to their researchers, they could not because it would be a “gift.”
If company got FDA approval to market for a rare disease, they could not pay the physician at JHU who ran the clinical trial, to talk to physicians around Maryland about how to use that drug to treat that rare disease, or even how to identify the symptoms of the rare disease within their patients because this would also be a “gift.”
Ms. Powell noted the critical need to tell HCPs about drugs once they are approved, how to use that product, what appropriate indications are, and when you can and cannot use it. She recognized that that FDA often requires training and education for drugs that have benefits/risks for patients.
She also emphasized that PhRMA believes there shouldn’t be gifts to encourage prescriptions, and how federal laws and anti-kickback laws already address this issue.
Gary Reno – Aisi Inc.
As a biopharmaceutical company, with 50 employees in Baltimore, Mr. Reno noted how his company makes products for treatments for brain tumors. He asserted that the federal laws are adequate enough not to need HB 818, and that if passed, the bill would have negative consequences for patients in Maryland.