PhRMA Criticizes Study of State Gift Disclosure Laws

A study claiming that two state pharmaceutical gift disclosure laws do not make payment information easily available to the public relied on inconsistent and mixed data, a top PhRMA official said.

An article in The Journal of the American Medical Association (JAMA) reviewed state laws in Vermont and Minnesota that require public disclosure of payments pharmaceutical companies make to physicians. The study found that the reported information is difficult to find and is of "limited quality."

Additionally, pharmaceutical companies find loopholes to keep payments private. In Vermont, 61 percent of payments were designated as trade secrets, the article said. In Minnesota, only 25 percent of companies disclose their payments each year.

The article's findings rely on an overly sophisticated analysis of the "mish-mash" of data from the two state laws, PhRMA Senior Vice President Ken Johnson said. The state laws "mix apples with oranges" because they include expenses from pharmaceutical representatives meeting with healthcare professionals as well as physician grants to academic research centers. The grants are usually designated for preclinical research work for companies developing new medicines and should not be included, Johnson added.

The article's authors admitted data reported under the state laws was inconsistent, but used it in their analysis anyway, Johnson said. The analysis is also unreliable because the authors only look at the advertising and marketing practices of pharmaceutical companies, which are a small part of the healthcare system, he added.

State disclosure laws are unnecessary, Johnson said, because companies already must comply with FDA regulations and Department of Justice laws on fraud and abuse. In addition, PhRMA provides voluntary marketing guidelines that say paying for any kind of entertainment is inappropriate and gifts should not exceed $100 in value.

Johnson also defended pharmaceutical company representatives meeting with healthcare providers, saying it is necessary for physician education.

The JAMA study shows the need to improve enforcement of existing disclosure laws and should help other states craft better ones, the article's authors said. At least 27 states will propose similar marketing legislation this year, according to the National Conference of State Legislatures.

( http://www.fdanews.com/did/6_58/ )