LANSING – Michigan House Democrats are working on a package of bills that would require the full disclosure of prescription drug tests for all drugs sold in Michigan. The legislation also would impose civil fines of $250,000 for the first offense and upward of $1 million for the third and subsequent offenses for companies that refuse to report or falsify test results.
Drug companies, under the legislation, would report their findings to the Department of Community Health, which would maintain a website with the information. House Democrats are also pushing for the package to restrict state funding for clinical tests if a company refuses to comply with the state disclosure and would also require companies to register results with the U.S. Department of Health and Human Services.
The Attorney General’s office would be required to investigate and prosecute any violations that have been brought to the state’s attention by DCH and AG staff, medical professionals and private citizens.
House Minority Leader Dianne Byrum (D-Onondaga) on Monday said the disclosure laws would reveal all test results – good or bad – so that consumers can be equipped to understand the medication they’ve been prescribed. More often, Byrum said, drug companies publish results that are positive, increasing their profits, than the results that may show a product is defective in some way.
Byrum said that U.S. Food and Drug Administration is “toothless” because of a fast-track policy that approves drugs with industry-supplied data, conflicts of interest between board members and the drugs they are approving and a general understaffing of the administration.
Maine is the only state so far to enact a registry targeting drugs sold there, although 15 other states have similar legislation pending. In 2004, the American Medical Association called for the creation of a national registry of prescription drug test results, after studies came back showing an increase in suicide risk for teenagers who took the antidepressant Paxil were hidden by its maker.
The National Institutes of Health runs ClinicalTrials.Gov, which is a voluntary disclosure database. Legislation to create a federal database has seen little movement in Congress.
The new legislation is part of the House Democratic Caucus’s drug industry lawsuit immunity repeal – a Republican sponsored bill before the Tort Reform Committee. Democrats have been attempting to tie-bar any bill before the full chamber to another drug immunity repeal bill, HB 4811, a strategy Byrum said will continue.
Rep. Kathy Angerer (D-Dundee), one of the sponsor’s of the new package, said she does not apologize for the tie-barring process, saying that constituents are supportive of the attempts to bring light to the issue.
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