Regulation of pharmaceuticals has been in place for nearly a century, starting with the Pure Food and Drugs Act of 1906 (which gave the government control over labeling of drugs), followed by the Food, Drug and Cosmetic Act in 1938 (which extended control over advertising and labeling and required proof that drugs were safe) and the1962 Amendments to the FDC Act (which added proof of efficacy to proof of safety as a criterion for drug approvals). The Duke Center for Health Policy and Inequalities Research has developed a draft working paper on the benefits and costs of pharmaceutical regulation.
- Half of all the clinical trials ever conducted and completed on the treatments in use today have never been published in academic journals.
- Trials with positive or flattering results, unsurprisingly, are about twice as likely to be published — and this is true for both academic research and industry studies.
- In 2005, the International Committee of Medical Journal Editors made an announcement: their members would never again publish any clinical trial unless its existence had been declared on a publicly accessible registry before the trial began. But a 2009 paper from The Journal of the American Medical Association reported that more than half of all trials published in leading journals still weren’t properly registered, and a quarter weren’t registered at all.
The Food and Drug Administration Amendments Act of 2007 required that new clinical trials conducted in the United States post summaries of their results at clinicaltrials.gov within a year of completion, or face a fine of $10,000 a day. But in 2012, the British Medical Journal published the first open audit of the process, which found that four out of five trials covered by the legislation had ignored the reporting requirements. No fine has yet been levied.
- The National Physicians Alliance has begun at alltrials.net demanding that results be publicly reported for all trials, dating back to at least the 1990s, on all treatments currently in use.
- US Food and Drug Law
- Food and Drug Administration
- Food and Drug Law Institute a non-profit organization providing a marketplace for discussing food and drug law issues through conferences, publications and member interaction.
- Pharmaceutical Quality Group
- Adverse Drug Events. Adverse Events, Inc. (AEI) is the only provider of up-to-the-minute, critical, potentially life-saving information regarding side effects associated with FDA-approved prescription medications. AEI has created a unique set of online tools that are optimized to provide un-paralleled access to adverse event information on over 4,000 drugs, in an easy to understand and navigate format. AEI’s tools give control over treatment plans back to patients and their doctors, while providing an immediate view of potential trends and problems in the drug industry to pharmaceutical, healthcare, insurers, financial institutions and media. RxFilter™ is a proprietary 17-step data refinement process developed by AdverseEvents, Inc. that standardizes and normalizes the Federal Drug Administration (FDA) Adverse Events Reporting System (AERS) database. Combining complex computer algorithms with hands-on data analysis by highly trained researchers, the RxFilter process is the most thorough optimization procedure ever applied to the FDA’s drug safety database. It accurately measures and tracks adverse events associated with medications reported to the FDA.