Compliance Resources to Help you Stay Current

FDA has released its Guidance Agenda for 2011 - it has been published in the Federal Register. The agenda functions as a Guide to Guides. The agency is not bound to adhere to the schedule. Thus, the Guidance on the Internet and Social Media is listed in the 2011 agenda although it figured in the 2010 agenda.  This throws up the following two possibilities:

• The draft guidance that the Division for Drug, Marketing and Advertising (DDMAC) hoped to release by the year-end may not be released. There was always a suspicion that some elements of the release were outside the jurisdiction of DDMAC
• More than one draft guidance could emerge.

In fact, a two-day public meeting in November 2009 covered the topic in detail and many believed that the draft guidance would not address the issues that emerged at the said meeting.  At best, multiple guidances divided among different subject matter jurisdictions might emerge. 

“Comparative Claims in Drug Promotion”, and “DTC Television Advertisements – DTC Pre-Review Program” figure under the category “Advertising” in addition to the guidance on “Promotion of Prescription Drug Products Using Social Media Tools”. 

By way of clinical trial designs, topics are slated for “Non-inferiority Trials” and “Adaptive Trial Designs”. Considerable activity is allocated for tobacco given FDA’s new authorities in this area.   However there is no suggestion of creation of a regulatory pathway for biosimilars. 

Regulations

The Food and Drug Administration (FDA) publishes its annual guidance document agenda. This list is published under FDA’s good guidance practices (GGPs) regulations. It is intended to seek public comment on possible topics for future guidance document development or revisions of existing ones. The general public can submit either electronic or written comments on this list and on any agency guidance document at any time.

Source:

http://www.eyeonfda.com/eye_on_fda/2010/12/fda-publishes-guidance-agenda-for-coming-year.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:+eyeonfda/

http://edocket.access.gpo.gov/2010/pdf/2010-30623.pdf

http://en.wikipedia.org/wiki/Food_and_Drug_Administration_Modernization_Act_of_1997

The FDA has been uncovering a number of harmful products marketed as dietary supplements for weight loss, body building and sexual enhancement. These products actually contain undeclared, active ingredients present in FDA-approved drugs or variations thereof. The FDA has caused the recall of nearly 200 inappropriately-formulated products since 2007. The recalled products were linked to reports of stroke, kidney failure, liver injury and death.

Vital community information will be provided shortly with the release of the U.S. Environmental Protection Agency’s (EPA) annual national analysis of the Toxics Release Inventory (TRI). Information on the disposal and release of toxic chemical into the air, land and water, and on waste management and pollution prevention activities in neighborhoods across America is published by the TRI program. The report claims that there has been a 12% decrease in the release of toxic chemicals into the environment from 2008, with the 2009 figures being 3.37 billion pounds.

Drug companies are not far behind tightening their control of faculty speakers, even as academic medical centers are facing the pressure to do the same.

Pharmaceutical companies have come under severe criticism as whistleblowers have launched lawsuits accusing them of using doctors to thrust their drugs/pills for non approved use over dinner conversations. The past three years has seen at least 10 companies settling lawsuits to the tune of approximately $7 billion. These companies have vowed to reform their ways as the threat of further punishment looms portentously.

Given this scenario, firms are now rigidly monitoring speakers. Seven companies are listed in ProPublica’s Dollars for Docs database – all of them are insisting that physicians use slide provided by the firm. This constraint is so designed as to fall in compliance with the U.S. Food and Drug Administration (FDA) regulations, necessitating speakers to discuss the approved uses of drugs only.

The contradiction comes with speakers violating universities’ policies if they follow the rules of the drug companies.

Dollars for docs

ProPublica is an independent, non-profit newsroom that produces investigative journalism in the public interest.

For many years, drug companies kept payment made to doctors to promote their drugs a secret. However, seven companies began to post the details of the same (name + compensation) on the internet, primarily due to legal issues/settlements. Ethical issues of the same rise even though receiving payment isn’t necessarily a wrongdoing.

A ProPublica investigation revealed that many doctors were paid speakers despite university bans, thus violating its policies. Compiled from disclosures by these seven companies, the discovery amounted to around $257.8 million in payouts since 2009 for speaking, consulting and other duties

A conflict of interest arises as academic medical institutions raise the issue of credibility of both the physicians and the institution they represent.

The new healthcare law

All drug companies will be required to publicly disclose payments to doctors as part of the new healthcare law by 2013.
 

Source

http://www.propublica.org/article/drug-companies-retain-tight-control-of-physicians-presentations

http://www.pbs.org/nbr/site/features/special/archives/pharmaceutical_companies/professors_violate_rules_accept_paid_speaking_roles_101220/

http://projects.propublica.org/docdollars/

http://www.propublica.org/article/dollars-to-doctors-physician-disciplinary-records

Privacy advocates criticized the U.S. Department of Commerce’s call on self-regulation for the online ad industry and the proposed "safe harbor" from the enforcement actions of the Federal Trade Commission (FTC).

The new report calls for a "Dynamic Privacy Framework" that would revitalize Fair Information Practice Principles (FIPPs). The paper recommends the creation of a Privacy Policy Office within the Commerce Department that would help develop voluntary privacy codes of conduct within a multi-stakeholder negotiation process.

The report drew flak due its shortfalls on the two areas, though some privacy advocates acclaimed the recognition of privacy issues. Many of the concerns surround the enormous gap between consumer privacy expectations and business reality in the online environment, where the general public is subjected to hidden tracking devices that are becoming increasingly sophisticated. The Commerce Department strongly supports greater adherence to the well-known Fair Information Practice Principles.

It also discusses the need to reform the Electronic Communications Privacy (ECPA) Act since cloud computing has drastically risen, and law enforcement agencies are concerned with data stored or traversing by service providers, keeping in line with the goals of the Digital Due Process coalition that the Electronic Frontier Foundation (EFF) is helping to steer.

Digital Due Process coalition

The "Digital Due Process" coalition includes major Internet and telecommunications companies like Google, Microsoft, and AT&T as well as advocacy groups such as the American Civil Liberties Union (ACLU) and the Center for Democracy & Technology (CDT). The coalition has joined together to preserve traditional privacy rights and clarify legal protections in the face of a rapidly changing technological landscape.

Electronic Communications Privacy Act

The Electronic Communications Privacy Act (ECPA) of 1986 was enacted by the United States Congress to extend government restrictions on wire taps from telephone calls to include transmissions of electronic data by computer. The ECPA has come under a cloud of criticism over the years including its failure to protect all communications and consumer records. Under the ECPA, a governmental agency can easily demand consumer data stored on servers from service providers with a written statement certifying that the information is relevant to an investigation of foreign counterintelligence with no judicial review required.
 

Source

http://www.eweek.com/c/a/Security/Commerce-Online-Privacy-Report-Gets-Mixed-Grades-661990/

https://www.eff.org/press/archives/2010/03/30

http://en.wikipedia.org/wiki/Electronic_Communications_Privacy_Act

The COBRA or Consolidated Omnibus Budget Reconciliation Act was passed in 1985 by the U.S. Congress. The Act’s most important regulations cover provisions for health benefits to workers and their families who lose their jobs. This part of the Act has gone through several changes in recent years since the recession hit, specifically its provisions for subsidy eligibilities. This article describes the background, key provisions and recent changes to this important Act.

The Public Company Accounting Oversight Board (PCAOB) released a regulatory compliance program overseeing the audits of brokers and dealers. This is its proposed interim inspection program. During the meeting held just before the release, the PCAOB initiated the regulation of audit securities of brokers and dealers. The meeting also addressed the issue of the support fee to fund that board’s extended broker-dealer oversight responsibility.

Some ticket vendors for airline ticket booking are not disclosing the airline carrier’s name at the time of booking a flight. This is despite the new Airline Safety Bill stating the immediate disclosure of the same.

Non compliance by ticket vendors has escalated to a big issue as the flying public is miffed by this tactic adopted by some ticket sellers. Airline ticket vendors have violated the new rules extensively by not clearly identifying the regional carriers for travelers.

The U.S. Environmental Protection Agency (EPA) celebrates its 30-year-old Superfund program as well as working towards making it stronger and more effective. It is focusing on dealing with cleaning up hazardous waste sites, a constantly changing challenge. The Superfund or the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) came into effect in December 1980 in order to deal with the sites in the United States that were the most complex, uncontrolled, polluted, or abandoned.

The 2011 Vulnerability Management Trends Research Report is revealed by eEye Digital Security (eEye), presenting awareness, answers, and insight into key issues in today’s vulnerability and compliance management. eEye also released Retina CS 2.0 (product version) along with the report with the automation of vulnerability and compliance management. eEye provides solutions in IT security and unified vulnerability management.

Brinkman Turkey Farms Inc. of Findlay, Ohio, recalled Brinkman's Gourmet Barbecue Sauce Jars (22 oz, 40 oz, 160 oz) bearing the codes, UPC# 033244000215,UPC# 033244000222 and UPC# 033244000208 from distribution. These products were distributed to retail stores, distribution centers and consumers in Ohio, Wisconsin, Michigan, Illinois, and Iowa. The recall was initiated because the product contained milk and soy distributed in packaging that did not reveal the presence of these ingredients. Milk and soy can cause serious to life-threatening reactions in individuals allergic to them.

The U.S market is currently flooded with various "environmentally-friendly" products of every category - from automobiles to groceries. More than 95% of consumer products marketed as "green," were found to have made spurious claims or indulged in "greenwashing." The Federal Trade Commission (FTC), the Better Business Bureau, the media and a growing number of consumer advocates are endeavoring to curb greenwashing by increasing self-regulatory efforts and stepping up enforcement of truth-in-advertising laws.

Tessalon (benzonatate) is an FDA-approved symptomatic cough relief drug for patients older than 10 years. However, this drug may attract younger children because of its candy-like appearance (round, liquid-filled gelatin capsule). The safety and effectiveness of benzonatate in children younger than 10 years has not been established. The FDA has therefore warned that accidental ingestion of Tessalon by children younger than 10 years can lead to serious side effects or even death.

In recent years, the FDA has uncovered a number of harmful products marketed as dietary supplements for sexual enhancement. These products actually contain active ingredients present in FDA-approved drugs or variations of these ingredients. Sexual enhancement supplements promising rapid or long-lasting effects are likely to contain the latter. The FDA has been urging consumers who have experienced negative side effects from such sexual enhancement products, to stop their usage and seek help from a health care professional.

The latest and perhaps the hottest trend witnessed nowadays among the world leading consumer companies is to evolve and be recognized as environment friendly companies. The newest to join the list are Procter and Gamble and Coca Cola.

The Securities and Exchange Commission (SEC) charged San Jose-based, RAE Systems Inc with violation of the Foreign Corrupt Practices Act (FCPA). It made payments amounting to USD 400,000 to Chinese officials to bag major government contracts worth approximately USD 3 million in revenue, for its gas and chemical detection products. The payments were made through two of its Chinese joint ventures, RAE-KLH (Beijing) Co., Limited (RAE-KLH) and RAE Coal Mine Safety Instruments (Fushun) Co., Ltd. (RAE-Fushun). RAE garnered USD 1.1 million plus in illicit profits.

The U.S Environmental Protection Agency (EPA) levied a penalty of USD 15,000 on two construction companies found violating the Clean Water Act at Flathead Lake in Flathead County, Montana. EPA also levied a fine of USD 10,000 on Dockmaster, Inc, a barge owner.

Pablo's Produce, Inc. of Oxnard, California, has voluntarily recalled one lot of cilantro bearing UPC # 03383801049 and sold between Nov 24, 2010 and Dec 2, 2010. The cilantro had been bundled with white twist ties, with the word "Cilantro" printed in black and the name of the supplier, "Pablo’s Produce of USA" printed in red and green.

The U.S government has sought reduction of air pollution from large ships. The reduction would apply to ships that operate in the coastlines of Puerto Rico and the U.S Virgin Islands. A proposal has been presented to the International Maritime Organization (IMO). It calls for defining these waters as an emission control area. Once so defined, large ships have to use cleaner fuel or install superior pollution control technology. Air Pollution in Puerto Rico and U.S Virgin Islands is mainly caused by tankers, container vessels and cruise ships.

A Pittsfield printing company, Interprint Inc, has agreed to shell out USD 80,000 as penalty and spend USD 305,000 to replace old, polluting wood stoves in Western Massachusetts. They will be replaced by cleaner models such as EPA-certified wood stoves or gas or propane heaters. This is in settlement of claims by the U.S Environmental Protection Agency (EPA) that charged Interprint with violating the federal Clean Air Act. The company will provide USD 1000 worth vouchers to each household to encourage replacement of the pre-1988 wood stoves.