The 7th and final Food Safety Modernization Act (FSMA) implementing rule is finally here and most companies will have three years to comply. On May 26, 2016, the FDA finalized the Mitigation Strategies to Protect Food Against Intentional Adulteration rule. The effective date of the rule is May 27, 2016, the date of the rule’s publication in the Federal Register. The rule implements the “food defense” provisions of the FSMA and aims to protect the public health from intentional adulteration acts, such as acts of terrorism targeting the food supply.
FDA approves first implantable buprenorphine maintenance treatment for opioid addiction
On May 26, 2016, the Food and Drug Administration (FDA) approved Probuphine as part of a targeted initiative by the U.S. Department of Health and Human Services (HHS) and the FDA to reduce prescription opioid and heroin-related overdose, death and dependence.
FDA finally unveils new nutrition facts label
Added Sugars are in. Calories From Fat are out. And would the typical American eat the package of food in one sitting? If so, those Americans will now know from the label what they will consume in that sitting.
Australia: Review of pharmaceutical reimbursement rules
Background
On 25 April 2015, the Minister for Health announced a review of the Guidelines (Guidelines) for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), the body that recommends which products should be reimbursed by Government, and for how much. The Minister said the review sought to ensure that the PBAC Guidelines are “consistent and transparent, while incorporating international best practice and removing any unnecessary regulatory burden on the pharmaceutical industry”. The review is being carried out by Adelaide Health Technology Assessment (AHTA) in conjunction with PBAC.
House bill addresses reduced payments to new off-campus hospital outpatient departments
On May 18, 2016, the U.S. House of Representatives Ways and Means Committee introduced the Helping Hospitals Improve Patient Care Act of 2016 (Act) to exempt certain newly-enrolled provider-based, off campus hospital outpatient departments (HOPDs) from reduced payments under the Bipartisan Budget Act of 2015 (BBA).
House and Senate pass Zika funding measures, but significant compromise still needed
The U.S. House of Representatives and the Senate each passed bills this week authorizing emergency spending to combat the
House passes comprehensive opioid legislation in advance of negotiations with the Senate
During the week ending May 13, 2016, the U.S. House of Representatives approved a comprehensive set of 18 bills aimed at curbing the opioid epidemic. The largest of these bills, the Comprehensive Opioid Abuse Reduction Act of 2016 (H.R. 5046), passed by a 413-5 vote in the House on May 12, 2016. This bill authorizes US $103 million dollars in grant funding for fiscal years 2017 through 2021, and makes the U.S. Department of Justice (DOJ) responsible for administering grants to state, local, and tribal governments to provide a range of opioid abuse services. These services include developing and expanding existing programs to combat opioid abuse, training first responders in administering opioid overdose reversal medication, and providing dedicated opioid treatment and prevention services for veterans. In March 2016, the Senate passed a similar measure, titled the Comprehensive Addiction and Recovery Act of 2016 (S. 524), which authorizes the Attorney General to award similar grants.
CMS seeks feedback on standard form for SRDP submissions
CMS has asked for comments on a form for healthcare providers to disclose actual or potential violations of the federal self-referral (Stark) law. The proposed format includes a disclosure form, a physician-information form, and a financial-analysis worksheet.
As many providers
Australia – nicotine and therapeutic goods
A recent Australian case (http://www.austlii.edu.au/au/cases/cth/FCA/2016/394.html) has touched on the tricky area of nicotine containing products, this time in the guise of product known as the Voke Inhalator, which contained 0.43mg of nicotine in a pressurised inhalation can. The supplier of the product was seeking to register the product as an OTC product, but our regulator, the Therapeutic Goods Administration (TGA), refused to consider the application, on the basis that the wrong form had been used.
TPP and biologics – a battleground in Australian elections
The Australian Labor Party has flagged the data exclusivity provisions of the Trans Pacific Partnership Agreement (TPP) as a major issue ahead of our now confirmed July date for an Australian election.