On January 13, 2014, the Food and Drug Administration ("FDA" or "the Agency") announced the availability of a much-anticipated draft guidance on its intended regulation of product promotion conducted via social media, titled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics ...
For more than twenty years, the federal government has attempted to limit the number of unsolicited phone calls consumers receive through the Telephone Consumer Protection Act, 47 U.S.C. § 227 (“TCPA”), which is perhaps best known for governing the famous “Do Not Call” list. Businesses, including banks and financial institutions, must understand the statute and stay abreast of its changes because the penalties for violating the TCPA are steep ...
Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...
More than three years after first announcing that it was considering issuing regulations applying the Americans with Disabilities Act to websites, the US Department of Justice (DOJ) appears on the verge of announcing its proposed rules for website accessibility. While the DOJ originally stated that it anticipated issuing its Title II website accessibility rules for websites operated by state and local governments by November 2013, it now expects to issue these rules by the end of the year ...
In recognition of the increasing popularity in the market of asset-backed contribution arrangements (ABCs), the Pensions Regulator has issued detailed guidance for trustees considering using such a structure to fund their pension scheme. ABCs, in general terms, allow an employer operating a defined benefit pension scheme to use a non-cash asset to provide a regular income stream to the scheme without an outright disposal of the asset to the scheme ...
On October 18, 2013, the Centers for Medicare & Medicaid Services (CMS) published Survey & Certification Letter 14-01-NM, which clarified the obligations of a skilled nursing facility (SNF) or nursing facility (NF) (collectively “nursing homes”) to provide cardiopulmonary resuscitation, or CPR, to its residents ...
In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...
As the fiscal year came an end at midnight on September 30, the House and Senate were unable to reach an agreement to fund the federal government and avoid a government shutdown. As a result, the White House Office of Management and Budget (OMB) has issued the order to implement the shutdown of the federal government. Although essential functions such as public safety and benefit payments will continue, the shutdown impacts all agencies funded through the annual appropriations process ...
After two years of operations, the SEC’s whistleblower program announced its first multimillion dollar award - a record $14 million payment to an anonymous tipster. The award is the largest of three announced since the program’s inception and emphatically signals the SEC’s continuing emphasis on its whistleblower program ...
When bankers and First Amendment lawyers encounter each other at cocktail parties, they can struggle to find common interests. Here is something to break the ice. In July 2010, President Obama signed into law the Dodd-Frank Act, the most comprehensive series of financial regulatory reform measures since the Great Depression. Just one year later, the United States Supreme Court issued Sorrell v. IMS Health, Inc., 131 S. Ct ...
Following a period of consultation, the Government has published regulations in relation to bridging pensions which will come into force on 1 October 2013. A number of pension schemes contain provisions dealing with bridging pensions, where a greater pension is paid from the scheme until the member reaches state pension age. As the state pension age is due to be increased over time the original provisions may no longer be appropriate ...
Never has there been a more controversial law in the past decade than the Reproductive Health Law (“RH Law”). After a long and contentious battle in Congress, the law was finally passed. But the fervent opposition by the so-called Pro-life groups (chief among them the Catholic Church) endures. Four days after the approval of the law’s Implementing Rules and Regulations (“IRR”), the Supreme Court on March 19, 2013, halted its implementation, issuing a 120-day status quo ante order ...
One of the more stirring reforms in the past two decades in the field of education is Republic Act 10533, or the Enhanced Basic Education Act of 2013 (“Enhanced Basic Education Act”) ...
The UK Information Commissioner’s Office (the “ICO”) experienced a surprising setback recently after the Information Rights Tribunal (the “Tribunal”) ruled that a fine of £250,000 issued by the ICO in relation to a breach of the Data Protection Act 1998 (the “DPA”) by Scottish Borders Council (the “Council”) was excessive ...
BackgroundFollowing much anticipation on the part of health care industry members, CMS released its long-awaited final rule on the Physician Payment Sunshine Act in February 2013, supplying clarification and guidance on new financial disclosure requirements governing pharmaceutical and medical device manufacturers. The rule includes extensive and potentially time-consuming mandates for drug and device companies, including reporting of annual payments to physicians and teaching hospitals ...
In Novozymes A/S v. DuPont Nutrition Biosciences APS, 2012-1433 (Fed. Cir. July 22, 2013), the Federal Circuit affirmed the district court’s grant of DuPont’s post-trial motion for judgment as a matter of law holding that Novozymes’ U.S. Patent No. 7,713,723 (“the ’723 patent”), directed to a variant of alpha-amylase, was invalid under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.2 (Slip op. at 18) ...
An American organization that finds itself involved in litigation in Canada, or an American attorney advising such an organization, will find most aspects of the Canadian civil justice system to be familiar. The legal systems of the two countries are comparable in many respects, they share common historical antecedents, and their core values are the same ...
Minister of Health Regulation No. 30 of 2013 on The Inclusion of Information on Sugar, Salt, and Fat Content, and Health Impact Messages for Processed and Fast Foods is aimed at lowering the exposure of the public to the risk of non-contagious disease such as hypertension, stroke, diabetes and heart attacks, which can be caused by the excessive consumption of processed or fast foods ...
The Minister of Health has issued Regulation No. 28 of 2013 on Affixing Health Warnings and Information on Tobacco Product Packaging which came into force on 12 April 2013, as a further implementation of Government Regulation No. 109 of 2012 on Control of AddictiveSubstances in the Form of Tobacco Products. The Regulation requires tobacco producers and importers to affix pictorial health warnings and health information on their tobacco products packaging ...
The Head of the National Drug and Food Control Agency (Badan Pengawas Obat dan Makanan – “BPOM”) recently issued Regulation No. 27 of 2013 on The Supervision of Drugs and Food Imports into Indonesian Territory which came into effect on 28 May 2013. This Regulation repeals and replaces the previous regulations on Imports of Processed Foods, Cosmetics and Drugs ...
Two years after the issuance of Law No. 6 of 2011 on Immigration (“Immigration Law”), its implementing regulation i.e. Government Regulation No. 31 of 2013 on The Implementation of Law No. 6 of 2011 on Immigration (“Reg. 31/2013”), was issued in order to provide further details on certain Articles of the Immigration Law. Reg. 31/2013 came into effect on 16 April 2013. Visas There are four types of visas under Reg ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
Myriad Genetics is known as a leader in the market for diagnostic testing of BRCA1 and BRCA2 gene mutations that have been linked to breast and ovarian cancer. These same diagnostic tests were recently in the celebrity press, as Angelina Jolie announced she had been tested positive for the mutations, resulting in her electing to have a preventative double mastectomy ...
Governor Perry recently signed four bills into law designed to combat Medicaid fraud, waste, and abuse. The bills are a mixed bag of enhanced enforcement capabilities for the state and a few new protections for healthcare providers. Most notably, the legislature made several changes to the Texas Medicaid Fraud Prevention Act (TMFPA), bringing the statute more in line with the federal False Claims Act. Changes to the Medicaid Fraud Laws On the enforcement side, S.B ...
