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FTC Staff: South Carolina Should Consider the Competitive Impact of Legislation Affecting Advanced Practice Registered Nurses

Federal Trade Commission staff submitted written comments on the competitive impact of legislative proposals to modify the supervision requirements imposed on Advanced Practice Registered Nurses (APRNs) in South Carolina. The comments are in response to a request from South Carolina State Representative Jenny A. Horne.

According to the comment by staff of the FTC’s Office of Policy Planning and its Bureaus of Competition and Economics, House Bill 3508 would impose more supervision requirements on most APRN categories, including nurse practitioners, certified nurse midwives, and clinical nurse specialists. House Bill 3078 would remove some supervision requirements, allowing APRNs to diagnose, order tests and therapeutics, and write prescriptions without a formal agreement with a particular supervising physician.

As stated in the comment, undue regulatory restrictions on APRN practice can impose significant competitive costs on patients and third-party payors, and may frustrate the development of innovative and effective models of team-based health care.

“We urge the South Carolina legislature to avoid restrictions on APRN practice that are not narrowly tailored to address well-founded patient safety concerns,” the comment states. “We urge legislators to consider the potential benefits of enhanced competition that H.3078 may facilitate and H.3508 may impede. If APRNs are better able to practice to the full extent of their education, training, and abilities, South Carolina health care consumers are likely to benefit from lower costs, additional innovation, and improved access to health care.”

The staff comment refers to an FTC staff policy paper, issued in March 2014, which analyzes the competitive implications of various types of APRN regulations.

The Commission vote to issue the staff comments was 4-0. (FTC File No. V160000; the staff contact is Daniel J. Gilman, Office of Policy Planning, 202-326-3136).

The FTC’s Office of Policy Planning works with the Commission and its staff to develop long-range competition and consumer policy initiatives, consistent with the FTC’s unique mission to conduct research and engage in advocacy on issues that affect competition, consumers, and the U.S. economy. The Office of Policy Planning submits advocacy filings; conducts research and studies; organizes public workshops; issues reports; and advises staff on cases raising new or complex policy and legal issues. To reach the Office of Policy Planning, send an e-mail to [email protected]. Like the FTC on Facebook, follow us on Twitter, read our blogs, and subscribe to press releases for the latest FTC news and resources.

FTC Requires Mylan to Sell Rights to Seven Generic Pharmaceuticals as a Condition of Acquiring Perrigo Company

Mylan N.V. has agreed to sell the rights and assets related to seven generic drugs in order to settle FTC charges that its proposed acquisition of Perrigo Company plc would be anticompetitive.

Both companies market generic drugs globally, and according to the FTC complaint, as originally proposed, the acquisition would likely harm competition in U.S. markets for seven generic pharmaceutical products. The settlement order preserves competition by requiring Mylan to divest the rights and assets in these product markets to the New Jersey-based generic pharmaceutical company Alvogen Group Inc.

The complaint alleges that the proposed acquisition would likely have harmed current competition in U.S. markets for four generic drugs. In these markets, both Mylan and Perrigo either are currently selling the drugs, or have approval of the Food and Drug Administration to do so:

Bromocriptine mesylate is used to treat conditions including type 2 diabetes and Parkinson’s disease.
Clindamycin phosphate/benzoyl peroxide is used to treat acne.
Liothyronine sodium is used to treat hypothyroidism and to treat or prevent enlarged thyroid glands.
Polyethylene glycol 3350 is a laxative used to treat occasional constipation.

The FTC’s settlement also will preserve future competition for three generic drugs. According to the complaint, the proposed acquisition would eliminate at least one likely future entrant from a very limited pool of future entrants in each of these markets:

Acyclovir is used to slow the growth and spread of the herpes virus in the body.
Hydromorphone hydrochloride is used to treat moderate to severe pain in narcotic-tolerant patients.
Scopolamine prevents symptoms associated with motion sickness and helps patients recover from anesthesia and surgery.

The proposed buyer, Alvogen, has the necessary resources, financial and technical capabilities, and experience marketing generic pharmaceutical products to replace successfully the competition that otherwise would have been lost through the proposed acquisition.

To ensure that the divestitures succeed, the proposed order requires Mylan to provide Alvogen with transitional services, including technical assistance. Further details about the divestitures are set forth in the analysis to aid public comment for this matter.

The Commission vote to issue the complaint and accept the proposed consent order for public comment was 4-0. The FTC will publish the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through December 3, 2015, after which the Commission will decide whether to make the proposed consent order final. Comments can be filed electronically or in paper form by following the instructions in the “Supplementary Information” section of the Federal Register notice.

NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $16,000 per day.

The FTC’s Bureau of Competition works with the Bureau of Economics to investigate alleged anticompetitive business practices and, when appropriate, recommends that the Commission take law enforcement action. To inform the Bureau about particular business practices, call 202-326-3300, send an e-mail to [email protected], or write to the Office of Policy and Coordination, Bureau of Competition, Federal Trade Commission, 600 Pennsylvania Ave., NW, Room CC-5422, Washington, DC 20580. To learn more about the Bureau of Competition, read Competition Counts. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.

FTC Announces Final Agenda, Panelists for Nov. 16 Cross-Device Tracking Workshop

The Federal Trade Commission has announced the final agenda for its upcoming workshop on the practice of tracking consumers across Internet-connected devices for advertising and marketing purposes and related consumer protection issues.

The half-day event, which will take place on Nov. 16 in Washington, D.C. at the FTC’s Constitution Center offices, will explore the practice known as “cross-device tracking.” As consumers use an increasingly diverse array of devices, from smart phones to tablets to wearable devices, they interact with platforms, applications, software and publishers in ways that were impossible to conceive even just a few years ago. The workshop will examine the practice of collecting data through these devices and the potential wide-ranging effects on consumer privacy.

FTC Chairwoman Edith Ramirez will provide opening remarks, followed by a presentation from Justin Brookman, policy director for the FTC’s Office of Technology, Research and Investigation, which will set the stage for two panel discussions featuring academics, technologists, consumer advocates and industry representatives.

The first panel will take an in-depth look at the technology behind cross-device tracking, including a look at how it has evolved, the benefits of the technology for businesses and consumers, as well as the privacy concerns and possible notice and choice mechanisms.

The second panel will examine the policy implications of cross-device tracking, including the nature of the data being collected about consumers, levels of consumer awareness of this form of tracking, ways in which consumers can receive notice of cross-device tracking practices and give meaningful consent, and how industry self-regulation efforts apply to tracking.

The workshop will take place in the FTC’s Constitution Center offices in the A, B, and C conference rooms located at 400 7th Street, SW, in Washington, D.C. The workshop is free and open to the public. Doors will open at 8 a.m. and the workshop begins at 9 a.m.

Full details are available on the workshop’s webpage. The workshop will be webcast live on the FTC’s website, and the event will be tweeted live from @FTC using the hashtag #FTCXDT.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.

FTC Approves Final Order Requiring Wet Wipe Manufacturer to Substantiate “Flushability” Advertising Claims

Following a public comment period, the Federal Trade Commission has approved a final consent order with Nice-Pak Products, Inc., requiring it to stop advertising moist toilet tissue and cloth as flushable or safe for sewer or septic systems unless it can substantiate those claims.

According to the FTC’s May 2015 complaint, Nice-Pak violated the FTC Act by misrepresenting that a certain formulation of its wipes: 1) are safe for sewer systems; 2) are safe for septic systems; 3) break apart shortly after being flushed; and 4) are safe to flush. The FTC also alleged Nice-Pak provided the means and instrumentalities for retailers and others that marketed the product under their own label to make similar misrepresentations.

The final order settling the complaint prohibits Nice-Pak from misrepresenting that any wipe is safe to flush, unless it can substantiate that the wipe will disperse in a sufficiently short amount of time after flushing to prevent clogging and/or damage to household plumbing, sewage lines, septic systems, and other standard wastewater treatment equipment.

Specifically, the substantiation must be based on the expertise of professionals in the relevant area and have been conducted and evaluated in an objective manner by qualified persons, using procedures generally accepted in the profession to yield accurate and reliable results. Those tests must substantially replicate the physical conditions of the claimed environment in which the item can be properly disposed.

Nice-Pak also is prohibited from making representations about any benefits, performance, or efficacy of moist toilet tissue, unless the statements are not misleading and the company relies on competent and reliable evidence.

The Commission vote approving the final order and 37 responses to public commenters was 4-0. (FTC File No. 132-3272; the staff contact is Sylvia Kundig, FTC Western Region Office, San Francisco, 415-848-5188.)

FTC Issues Final Orders Settling Charges of Illegal Agreement not to Compete

Following a public comment period, the Federal Trade Commission has approved final orders settling charges that pharmaceutical companies Concordia Pharmaceuticals Inc. and Par Pharmaceutical, Inc. entered into an unlawful agreement not to compete in the sale of generic versions of Kapvay, a prescription drug used to treat attention deficit hyperactivity disorder.

Under the orders, first announced in August 2015, the companies agreed not to enforce the anticompetitive provisions of their agreement. The companies also are prohibited from agreeing with other entities to bar or delay entry of an authorized generic after the patents covering the branded product have expired.

The FTC originally named private equity fund TPG Partners VI, L.P. – the parent of Par at the time – as a respondent. However, due to TPG’s recent sale of Par, the Commission has removed TPG as a respondent and modified the complaint and the decision and orders accordingly.

The Commission vote approving the final orders was 4-0. (FTC File No. 151 0030; the staff contact is Bradley S. Albert, Bureau of Competition, 202-326-3670)

FTC Dismisses Complaint against Steris and Synergy

The Federal Trade Commission has voted unanimously to dismiss its administrative complaint challenging Steris Corporation’s proposed $1.9 billion acquisition of Synergy Health plc. The FTC had filed a lawsuit in federal court seeking an injunction to prevent the acquisition from going forward pending the outcome of administrative litigation, but the court denied the motion, and the Commission did not appeal that decision.

“Although we still have competitive concerns about this acquisition, we have concluded that further adjudication would not serve the public interest,” the Commission wrote in a statement. The Commission cited the fact that “the district court’s denial of preliminary relief would render it difficult for us to craft meaningful relief were we to find the merger unlawful at the conclusion of the administrative proceeding.”

Both the federal court complaint and the administrative complaint alleged that the challenged acquisition would violate the antitrust laws by eliminating the likely future competition between Steris’s gamma sterilization facilities and Synergy’s planned x-ray sterilization facilities in certain regional markets in the United States, thus depriving customers of an alternative sterilization service and additional competition.

The Commission vote to approve the Commission statement and dismiss the administrative complaint was 4-0. (FTC File No. 151 0032; the staff contact is Amy Posner, Bureau of Competition, 202-326-2614)

FTC Staff Provides Comments to FDA on Naming Proposal for Biologic Products

The staff of the Federal Trade Commission has submitted a comment to the U.S. Food and Drug Administration in response to the FDA’s request for comment on its draft guidance addressing nonproprietary names for biological products. The staff comment expresses concern that the FDA draft guidance on biosimilar naming may hinder competition, and recommends that the agency consider alternatives.

In its draft guidance, “Nonproprietary Naming of Biological Products: Guidance for Industry,” the FDA proposes adding a new, random suffix to the nonproprietary name of each biological product. The purpose of the FDA’s naming convention is to improve pharmacovigilance and minimize possible inadvertent substitution of biological products that the FDA has not determined to be interchangeable.

Building on the FTC’s extensive experience in evaluating healthcare competition and studying competitive issues affecting biologics, the staff comment suggests that the FDA’s naming convention, which departs from the FDA tradition, may cause physicians to believe mistakenly that the products necessarily have clinically meaningful differences, potentially resulting in reduced price competition in biologic drug markets.

The comment also notes ways in which the naming proposal may create unnecessary costs, and conflicts with efforts toward global naming harmonization.

Finally, the comment asks the FDA to reconsider its proposal and suggests alternatives with less impact on competition that could achieve FDA’s purpose to avoid inadvertent substitution and improve the reporting of adverse events involving biologics to the FDA.

The Commission vote approving the staff comment was 4-0. (FTC File No. P131208; the staff contact is Elizabeth Jex, Office of Policy Planning, 202-326-3273)

The FTC’s Office of Policy Planning works with the Commission and its staff to develop long-range competition and consumer policy initiatives, consistent with the FTC’s unique mission to conduct research and engage in advocacy on issues that affect competition, consumers, and the U.S. economy. The Office of Policy Planning submits advocacy filings; conducts research and studies; organizes public workshops; issues reports; and advises staff on cases raising new or complex policy and legal issues. To reach the Office of Policy Planning, send an e-mail to [email protected] (link sends e-mail). Like the FTC on Facebook (link is external), follow us on Twitter (link is external), read our blogs, and subscribe to press releases for the latest FTC news and resources.

Marketer of Rug Accessory Settles FTC Charges of Invitation to Collude with Competitor

A company that sells rug accessories designed to keep rugs from curling at the corners has agreed to settle Federal Trade Commission charges that it illegally invited its closest competitor to coordinate prices.

The company, Step N Grip, LLC, sells NeverCurl, a product that can be attached to the corners of a rug so that they stay flat on the floor. Like its closest competitor, Step N Grip sells most of its inventory on Amazon.com, according to the FTC.

The complaint alleges that earlier this year, Step N Grip and its closest competitor, identified as Competitor A, reduced their prices to compete with each other and gain sales. After a week of this rivalry, Step N Grip approached Competitor A, proposing that it agree to fix and raise the price of their competing rug devices. Competitor A reported the invitation to collude to the FTC. According to the FTC, Step N Grip’s invitation to collude was an unfair method of competition that violated Section 5 of the Federal Trade Commission Act.

Under the proposed settlement agreement, Step N Grip is required to stop communicating with its competitors about prices. It is also barred from entering into, participating in, inviting, or soliciting an agreement with any competitor to divide markets, to allocate customers, or to fix prices; and from urging any competitor to raise, fix, or maintain its price or rate levels or limit or reduce service. The order is in effect for 20 years.

Details about the case are set forth in the analysis to aid public comment for this matter. The Commission vote to issue the complaint and accept the proposed consent order for public comment was 4-0.

The FTC will publish the consent package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through November 27, 2015, after which the Commission will decide whether to make the proposed consent order final. Comments can be filed electronically or in paper form by following the instructions in the “Supplementary Information” section of the Federal Register notice.

The FTC’s Bureau of Competition works with the Bureau of Economics to investigate alleged anticompetitive business practices and, when appropriate, recommends that the Commission take law enforcement action. To inform the Bureau about particular business practices, call 202-326-3300, send an e-mail to antitrust{at}ftc{dot}gov, or write to the Office of Policy and Coordination, Bureau of Competition, Federal Trade Commission, 600 Pennsylvania Ave., NW, Room CC-5422, Washington, DC 20580. To learn more about the Bureau of Competition, read Competition Counts. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.

FTC and Seven International Partners Launch New Initiative to Boost Cooperation In Protecting Consumer Privacy

The Federal Trade Commission and enforcement agencies from seven other countries launched a new information-sharing system that will enable them to better coordinate international efforts in protecting consumer privacy.

On Sunday October 25, FTC Chairwoman Edith Ramirez joined representatives from several agencies, which are members of the Global Privacy Enforcement Network (GPEN), in signing a Memorandum of Understanding among users of the new system, called GPEN Alert. The signing took place at the 37^th International Conference of Data Protection and Privacy Commissioners in Amsterdam.

“Today, data is increasingly crossing borders, and our privacy investigations and enforcement must do the same,” Chairwoman Ramirez said. “GPEN Alert is an important, practical cooperation tool that will help GPEN authorities protect consumer privacy across the globe.”

GPEN Alert is a multilateral system that will enhance coordination by enabling participants to confidentially share information about investigations. The GPEN Alert technology is based on the FTC’s Consumer Sentinel Network, a system that enables member U.S. law enforcement agencies to access complaints that consumers provide to the FTC and other data contributors.

The seven international partners joining the FTC as initial participants in GPEN Alert are:

Australia: Office of the Australian Information Commissioner
Canada: Office of the Privacy Commissioner
Ireland: Office of the Data Protection Commissioner
Netherlands: Data Protection Authority (“College Bescherming Persoonsgegevens”)
New Zealand: Office of the Privacy Commissioner
Norway: Data Protection Authority (“Datatilsynet”)
United Kingdom: Information Commissioner’s Office

The FTC is grateful for the financial contributions of several agencies to the development of the GPEN Alert technology. Contributions were received from British Columbia, Canada, the United Kingdom, Norway, Australia, Ireland and New Zealand.

The Commission vote authorizing Chairwoman Ramirez to sign the MOU on behalf of the agency was 5-0.

As more U.S. companies and consumers do business overseas, more FTC work involves international cooperation. The Office of International Affairs serves both as an internal resource to Commission staff on international aspects of their work and as an official representative to numerous international organizations. In addition, the FTC cooperates with foreign authorities through formal and informal agreements. The FTC works with more than 100 foreign competition and consumer protection authorities around the world to promote sound policy approaches. For questions about the Office of International Affairs, send an e-mail to [email protected]. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases and the FTC International Monthly for the latest FTC news and resources.

FTC Action Bans Scammers from Advance Fee Recovery Business

The operators of an advance fee recovery scheme that falsely claimed it could recover money for consumers that they had lost to telemarketing scams will be banned from selling recovery services, and from telemarketing, under a court order issued at the Federal Trade Commission’s request.

The court order resolves a 2014 FTC complaint that charged Consumer Collection Advocates and Michael Robert Ettus with illegally collecting money from consumers, many of them elderly people harmed by timeshare resale and precious metal investment frauds. The court subsequently prohibited the defendants, pending resolution of the case, from misrepresenting that consumers who bought their services would recover, or were likely to recover, a substantial portion of money they had lost.

The final order of permanent injunction announced today also prohibits the defendants from misrepresenting any product or service, collecting payments for any recovery service, selling rights to collect for such service, profiting from customers’ personal information, and failing to properly dispose of customer information. The order imposes a judgment of more than $2.8 million.

The U.S. District Court for the Southern District of Florida issued the final order of permanent injunction on September 28, 2015. The court granted the FTC’s motion for summary judgment on September 9, 2015. The defendants have appealed the court’s decision.

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