Drug industry advertising and marketing activities are linked to higher prices, improper prescribing, off-label marketing and invasion of privacy. Although regulation of advertising and marketing has traditionally been the province of the federal government, states are tackling the issue in a variety of ways. NLARx is working with state legislators to rein in harmful marketing and advertising practices through initiatives to disclose industry spending on direct to consumer advertising, gifts to providers and other marketing campaigns; regulate drug detailers; promote independent “academic” detailing programs; establish conflict of interest rules; protect patient and doctor privacy by restricting the commercial use of prescription data; and beef up state authority to enforce federal misleading advertising and consumer fraud rules and enforcement. Recent state legislation inlcudes Vermont Bill S. 48.

Researching this Issue

Model laws and best practices, testimony supporting these initiatives, and background information and research materials including reports, legal briefs, and news articles on direct to consumer advertising, pharmaceutical marketing and detailers, data mining and confidentiality issues are posted here. Other relevant materials may be found on the issue page relating to Safety & Clinical Trials, which has materials and policies on academic detailing and posting of drug efficacy and safety data, on the Pharma Watch page which details the promotional and lobbying activities of the pharmaceutical industry, and on the Medicare & Medicaid page which include information on state False Claims Acts and lawsuits enforcing state and federal fraud laws. See also the Related Links below to connect to other organizations and materials relevant to this issue.

Legal Challenges to State Laws Protecting Prescriber Data

New Hampshire, Vermont and Maine have each passed laws to prohibit the sale of confidential prescriber data for marketing purposes. The laws have subsequently been challenged by datamining firms in the Courts. In November 2008, the First Circuit Court of Appeals upheld the constitutionality of New Hampshire's law. NLARx has pages with the relevent documents for the cases in each state:


Model Legislation
May 27, 2009
Bill Summary and Press Release on the Passage of Sweeping Vermont Gift Ban (S. 48) | >>more
May 21, 2009
Bill to Ban Predatory Marketing to Minors Enacted in Maine | >>more
May 21, 2009
Ohio Rep. Skindell Reintroduces HB 94, the Ethical Marketing Disclosure Act | >>more
>> view all Model Legislation
 
Testimony
Jun 24, 2010
Comments on FDA Regs for TV Drug Ads | >>more
Nov 12, 2009
Transcripts of FDA's November 2009 Public Hearing on Social Media Available | >>more
Oct 27, 2009
Testimony on the Advisability of Requiring Disclosure of Free Samples of Prescribed Products given to Vermont Health Care Providers | >>more
>> view all Testimony
 
Legal Briefs and Opinions
Sep 15, 2009
IMS v. Vermont Update | >>more
Jun 23, 2008
Consumer Groups Defend Vermont Prescription Data Privacy Law  | >>more
Nov 19, 2007
First Circuit Decision Signals Hurdles for Whistleblowers in Off-Label Promotion Cases | >>more
>> view all Legal Briefs & Opinions
here
Related News
Jul 23, 2010
Vermont Press Bureau
Massachusetts set to repeal Pharma law; will Vermont follow? | >>more
Jul 23, 2010
Pharmalot
Glaxo Takes a $2.4B Legal Charge on Avandia & Paxil | >>more
Jul 22, 2010
PostScipt Blog
Harvard Med Bolsters COI Policy: Will Other Schools Follow Suit? | >>more
>> view all News
 
Reports
Jun 24, 2010
Ghostwriting in Medical Literature | >>more
Dec 03, 2009
Tighter Controls Recommended to Prevent Conflicts of Interest Between Doctors and Pharmaceutical Companies | >>more
Dec 02, 2009
Promotional Spending for Prescription Drugs | >>more
>> view all Reports
 
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