Looking to wrap up their legislative session by this weekend, the Vermont Senate easily passed a major health care reform bill, which included provisions about disclosure and gifts from drug and device companies. The health care reform bill, S.88, which was strongly supported by a voice vote, included a small win for patients because it approved an amendment to the prescription drug provisions that removed the public reporting of free samples. Although heavily debated, the provision, which was offered by Sen. Richard Sears, D-Bennington, passed with a vote of 18-10.
In addition, the bill prohibits any manufacturer of a prescribed product or any wholesale distributor of medical devices, or any agent thereof, to offer or give any gift to a health care provider. The bill does not prohibit any of the following:
– Samples of a prescribed product or reasonable quantities of an over-the-counter drug, nonprescription medical device, or item of nonprescription durable medical equipment provided to a health care provider for free distribution to patients;
– The loan of a medical device for a short-term trial period, not to exceed 90 days, to permit evaluation of a medical device by a health care provider or patient;
– The provision of reasonable quantities of medical device demonstration or evaluation units to a health care provider to assess the appropriate use and function of the product and determine whether and when to use or recommend the product in the future;
– The provision, distribution, dissemination, or receipt of peer-reviewed academic, scientific, or clinical articles or journals and other items that serve a genuine educational function provided to a health care provider for the benefit of patients;
– Scholarship or other support for medical students, residents, and fellows to attend a significant educational, scientific, or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship or other support is selected by the association;
– Rebates and discounts for prescribed products provided in the normal course of business;
– Labels approved by the federal Food and Drug Administration for prescribed products;
– The provision of free prescription drugs or over-the-counter drugs, medical devices, biological products, medical equipment or supplies, or financial donations to a free clinic;
– The provision of free prescription drugs to or on behalf of an individual through a prescription drug manufacturer’s patient assistance program;
– The provision of coffee, snacks or refreshments at a booth at a conference/seminar; and
– Fellowship salary support provided to fellows through grants from manufacturers of prescribed products, provided:
(i) such grants are applied for by an academic institution or hospital;
(ii) the institution or hospital selects the recipient fellows;
(iii) the manufacturer imposes no further demands or limits on the institution’s,
hospital’s, or fellow’s use of the funds; and
(iv) fellowships are not named for a manufacturer, and no individual recipient’s
fellowship is attributed to a particular manufacturer of prescribed products.
With regards to disclosure, S.88 requires that on or by October 1, every manufacturer of prescribed products annually disclose to the office of the attorney general for the fiscal year ending the previous June 30th the value, nature, purpose, and recipient information of any allowable expenditure or gift under the legislation except:
– Royalties and licensing fees;
– Rebates and discounts for products prescribed in the normal course of business; and
– Payments for clinical trials;
– Interview expenses (for hiring employees); and
– Coffee or other snacks or refreshments at a booth at a conference or seminar.
All payments to an academic institution, nonprofit hospital foundation, or to a professional, educational, or patient organization are the same as above, but do not include exceptions for interview expenses and coffee/snacks.
Payments for clinical trials must be disclosed after the earlier of the date of the approval or clearance of the prescribed product by the FDA or two calendar years after the date the payment was made. In addition, for a clinical trial for which disclosure is delayed, the manufacturer must still identify to the attorney general the clinical trial, the start date, and the web link to the clinical trial registration on the national clinical trials registry.
The newly amended bill adds a requirement that annually on or before October 1 of each year, each manufacturer of prescribed products must disclose to the office of the attorney general all free samples of prescribed products, including starter packs, provided to health care providers during the fiscal year ending the previous June 30, identifying for each sample the product, recipient, number of units, and dosage. The data on free samples would only be available to the attorney general’s office.
The legislation allows the attorney general to contract with academic researchers to release data relating to manufacturer distribution of free samples for purposes of analysis. The data would not include the names or license numbers of individual recipients. If such information is made public, it will not identify individual recipients of samples or connect individual recipients with the monetary value of the samples provided.
Manufacturers of prescribed products would also have to report each allowable expenditure or gift, the value, nature, and purpose of each allowable expenditure, and gift, as well as;
– The name of the recipient;
– The recipient’s address;
– The recipient’s institutional affiliation;
– The prescribed product or products being marketed, if any; and
– The recipient’s state board number.
Companies will also have to pay an annual $500.00 fee for filing annual disclosures, and will have to tell the attorney general the name and address of the individual responsible for the manufacturer’s compliance with disclosure and gifts. Violations of gifts and disclosure requirements can result in a civil penalty of no more than $10,000.00 per violation.
Impact on Patients
The success of this amendment and bill is crucial for patients who depend on free samples, such as low-income individuals. While critics believe that free samples are nothing more “than a marketing attempt to promote new and more expensive medications,” we remind them that 75% of drugs in America prescribed are generics.
The fact that one survey showed 38 percent of doctors might stop accepting samples if that information was made public is extremely disturbing. Think about how many patients will be prevented access to new and life changing medicines if that many doctors stop giving out samples.
The success of this amendment is also important because Vermont has banned most financial contact between the companies that make drugs and the physicians that prescribe them. Any further hindrance between industry and physicians will surely hurt patients, and Vermont doctors are vocal about this point.
In fact, “many lawmakers heard concern about the free sample provision from their local doctors.” One of the most vocal critics of the provision was Dr. Deb Richter of Montpelier, who said the “proposal implies that doctors are doing something unethical.”
Dr. Richter, along with five other doctors wrote a letter to Attorney General William Sorrell calling this claim “offensive,” and asserting that the “implication that doctors prescribing patterns are influenced by the samples they receive” was flat out wrong.
Ultimately, Mr. Sears introduced the amendment because he was worried that the provision would have a "chilling effect" on doctors in Vermont, which would lead them to no longer accept the free drug samples from the pharmaceutical companies. Without the use of such samples, patients would be harmed because physicians would not be able to test potential treatments and options for their patients. As a patient, would you turn down a free sample from a physician if it could help you or lead you to gain better control of your health problems?
Vermont Legislature
S-88 Prescription Products Provision
S-88 Full Text of Bill (Passed by State Senate)
Media
Montpelier Times Argus: Lawmakers Weigh Sample Drug Oversight
Vermont Public Radio: Should Drug Samples Be Reported