On October 11, 2018, the Occupational Health and Safety Administration (OSHA) issued a memorandum to clarify its position regarding whether drug testing policies and safety incentive programs would be considered violations of OSHA’s regulations. Employers may recall that, in May 2016, OSHA published a final rule that, among other requirements, prohibited employers from retaliating against employees for reporting work-related injuries or illnesses. That portion of the final rule became known as the Anti-Retaliation Rule. Almost immediately, there was confusion over which workplace safety incentive programs and post-incident drug testing policies, if any, were permissible under the final rule. OSHA originally took the position that certain programs and policies could deter employees form reporting work-related injuries and illnesses, thus violating the Anti-Retaliation Rule. OSHA has now clarified that the Anti-Retaliation Rule does not prohibit workplace safety incentive programs and post-incident drug testing.
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Reporting
FDA Provides Guidance on Postmarketing Safety Reporting for Combination Products
By Robinson+Cole's Health Law Group on
On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products. The FDA had previously issued a Final Rule on PMSR for combination products on December 20, 2016 (PMSR Final Rule).
By way of background, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because PMSR regulations for medical products in different categories are individualized (for example, PMSR are different for drugs than they are for medical devices and biological products), the two new guidance documents clarify the PMSR requirements that apply when a product is comprised of multiple medical categories. According to the FDA, these documents were issued in an effort to further interpret the Final Rule by ensuring consistent and complete reporting while simultaneously avoiding duplication in reports.
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