November 22, 2011

Contact: (202) 835-3323, media@nclnet.org

Washington, DC–As Americans return to the workplace next Monday after the long holiday weekend, many will spend a portion of their day surfing the Internet for deals from online retailers. Monday, November 28 — “Cyber Monday” – is what the retail industry claims to be one of, if not the, busiest Internet shopping days of the year, and with more and more consumers opting to avoid the mall, e-shopping next week is expected to be higher than ever. As reported in the Wall Street Journal, spending on Cyber Monday will be around $1.2 billion, a prediction by research-firm comScore Inc.

Whether consumers do their shopping online at the workplace or at home, advocates are reminding them to practice safe e-shopping habits in the coming weeks and year-round. “The Internet can make your shopping faster and easier, but there can also be pitfalls if you’re not careful,” said Sally Greenberg, executive director of the National Consumers League, which today released its top ten tips for avoiding cyber grinches and scams this holiday season. “There are ways to ensure you have a safe online shopping experience, so that gift-giving is a joyous occasion, not an opportunity for cyber thieves.”

1. Don’t shop online on an unencrypted or open wireless network. As convenient as they seem, an airport or coffee shop’s wireless network is not an appropriate place to conduct financial transactions. Entering personal financial information over an unsecured connection may leave your computer open the to hackers and thieves to capture your financial information. Home Wi-Fi networks can also be compromised, so consumers should find out how to secure their connections.

1. Secure your computer before shopping online. Before connecting to the Internet or shopping online, take the following three core protections: 1) Install anti-virus and anti-spyware programs and keep them up to date; 2) Install a personal firewall; 3) Regularly update operating system and anti-virus programs to current protections.

1. Know who you’re dealing with. Before shopping online with an unknown e-store, check out the seller and be sure to get the name and physical address of the vendor in case something goes wrong. If you’re buying gifts on an online auction site, check the track record of the seller before you bid.

1. Pay the safest way – by credit card, especially when you’re purchasing something that will be delivered later. Under federal law you can dispute the charges if you don’t get what you were promised. You may also dispute unauthorized charges on your credit card. Consider using a “virtual” credit card number.  These numbers replace your plastic credit card number with a new number that is linked to your real account number.  When you’re prompted to enter your credit card number at checkout, you enter the virtual number instead of the real number.  These “virtual” numbers can be set to have a low credit limit, to only work at certain Web sites, or to expire after a certain period of time (two months from date of purchase is a good rule of thumb).  This way, if the Web site you’re shopping at is compromised, the crooks likely won’t be able to run up charges on your real credit account since the virtual number.  A note of caution, however: think twice before using a virtual credit card number for services where you will be billed repeatedly or for things like rental car reservations, since the card may not be billed until you pick up the car.

1. Only shop on safe sites. When providing payment information, the Web site URL address should change from “http” to “https,” (or, less frequently, “shttp”) indicating that the purchase is encrypted or secured. Look for an icon on the browser (generally in the bottom right of the window), such as an image of a padlock closing, to indicate that the page is secure.

1. Don’t fall for a phishing email or pop-up. Legitimate companies don’t send unsolicited email messages asking for your password, login name, or your financial information. But scammers do, and it’s called “phishing.” Crooks often send emails that look like they’re from legitimate companies – but direct you to click on a link, where they ask for your personal information. Delete these emails.

1. Be careful when shopping for a gift in an online auction. Consumers sometimes turn to auctions for harder-to-find collectibles or expensive electronics. Understand how the auction works, and check out the seller’s reputation before you bid. Use safe ways to pay, like a credit card. If you use a 3rd party payment system, read the terms carefully to understand what protection, if any, it offers if you don’t receive what you were promised. Always ask about terms of delivery and return options. Be especially wary of auctions that ask for payment via wire transfer.

1. Turn your computer off when you’re finished shopping. Many people leave their computers running 24/7, the dream scenario for scammers who want to install malicious software—“malware”—on your machine and then control it remotely to enable them to commit cyber crime. To be extra safe, switch off your computer when you are not using it.

1. Don’t be tempted by offers of free money. Con artists take advantage of cash-strapped consumers during the holidays to offer personal loans or credit cards for a fee upfront. These scammers simply take the money and run. Beware of emails offering loans or credit, especially if you have credit problems.

10.  Visit www.fraud.org to learn more about protecting yourself from online scams year-round and to report suspicious sites, sellers, or scams. You don’t have to be a victim to report a scam, and your information will help law enforcement go after cyber grinches.

Above all, look into the business or individual with whom you are doing business before making the transaction. For more information on avoiding scams throughout the year, visit www.fraud.org.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

November 4, 2011

Contact: NCL Communications, (202) 835-3323, media@nclnet.org

Washington, DC-Sally Greenberg, Executive Director of the National Consumers League, issued this statement in support of the Wireless Tax Fairness Act HR 1002, which will be voted on by the US House of Representatives this evening.

“The National Consumers League supports HR 1002, the Wireless Tax Fairness Action of 2011, because it will slow the exploding number of taxes imposed on consumers and users of wireless phones and other services. Consumers in 46 states now pay wireless taxes, fees, and government charges that exceed the retail sales tax rate.

For millions of Americans, cell phones have replaced landlines in providing phone services. The millions of consumers who receive a cell phone bill each month- and many of these customers are middle and lower middle income Americans- with taxes imposed that they don’t understand – in some states a gross receipts tax is imposed on top of a sales tax –are paying taxes that add significantly to their overall bill. Unfortunately, without this legislation, there appears to be no end in sight; state and local governments will continue treat consumers who use wireless devices as a “cash cow” for local projects.

The NCL understands that state and local governments need to raise revenues to pay for essential services – fire and ambulance, schools and hospitals, roads and infrastructure -and we support their right to do so through a democratic process, which includes the passage of tax laws that are supported by the citizens. The ever-increasing taxes imposed on consumers who use wireless services are the wrong approach, however, and have reached unacceptable levels. This bill’s moratorium will give state and local governments the opportunity to join with consumers and others in an effort to reform communications taxes, an effort that is long overdue.”

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

October 31, 2011

Contact: NCL Communications, (202) 835-3323, media@nclnet.org

Washington, DC—The National Consumers League mourns the death this month of Virginia Knauer, who served as head of the Office of Consumer Affairs under Presidents Richard Nixon, Gerald R. Ford, and Ronald Reagan. Knauer was a friend and colleague of the League, and she spoke out on a range of consumer issues that are as important today as they were in 1969 when she was appointed.

“Ginny Knauer was an important ally in the fight for consumer protection. She called for consumers to have the right to bring class-action suits, not just in states, but in federal courts; she argued for a comprehensive system of product safety standards and simpler language in product warranties,” said Jane King, NCL’s Board Chair. “She was ahead of her time.”

Anna Flores, who serves on NCL’s Board of Directors and worked with the staff at the U.S. Office of Consumer Affairs, said about Knauer: “She used the bully pulpit on behalf of consumers in speeches around the country—including her observation that ‘the consumer is getting fed up with shoddy material, poor quality, unsafe products, bad service, weak warranties, lack of adequate information’. Her voice on behalf of consumers was very important; indeed, this is a voice that is sorely missing in today’s political discourse.”

Knauer called herself a “pipeline to the President for consumers”  and she certainly was. She served as spokeswoman for consumer rights and protections during an important period in American history. While NCL is saddened by the passing of Virginia Knauer, the League gratefully acknowledges Knauer’s unflinching advocacy on behalf of consumers.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

October 24, 2011

 

Docket No. FDA-2010-N-0128

Public hearing statement on re-authorization of the Prescription Drug User Fee Act by Sally Greenberg, Executive Director, National Consumers League before the U.S. Food and Drug Administration

Good morning. On behalf of the National Consumers League (NCL), I would like to thank you for the invitation to share a consumer-oriented perspective on proposed recommendations for the re-authorization of the prescription drug user fee act (PDUFA 5).

Established in 1899, NCL is the nation’s oldest nonprofit consumer education and advocacy organization. NCL provides government, businesses, and other organizations with the consumer’s perspective on numerous policy issues including child labor, privacy, food safety, and medication safety and information. From the first Pure Food and Drugs Act passed in 1906 to the more recent FDA Modernization Act, NCL has been working – often alongside the Agency – to ensure that the public is adequately represented and protected, and that our medications are safe and effective.

It is in this context that NCL expresses concern that many of the recommendations for this re-authorization of PDUFA are focused on reducing perceived barriers to new drug approvals rather than on protecting and promoting the health of patients and consumers by ensuring access to safe and effective medications. The other consumer groups represented on this panel, all members of the Patient, Consumer and Public Health Coalition, also share this overriding concern.

NCL believes that we should have a drug approval process that provides timely access to safe and effective drugs while reducing exposure to harmful drugs that pose undue risk. We recognize that PDUFA must balance the needs of consumers who are concerned about serious side effects with the concerns of patients who may be facing a life-threatening illness where time is of the essence. Thus, while it is important to have an efficient and timely approval process, there is still, in our view, too little emphasis on performance goals aimed at improving the safety and efficacy of drugs.

We continue to be concerned that the public has too little opportunity to fully engage in the PDUFA process. While we appreciate the FDA’s efforts to keep stakeholders informed about the negotiations and to solicit our input on the proposals under discussion, consumer and patient groups were not present during the negotiations, and, as a result, several patient safety and consumer protection initiatives that were put forward were never discussed in the formal dialogue with industry. We believe that the PDUFA proposal should not be move forward without these additional provisions. I will be addressing several of those issues today.

1. Direct to Consumer Advertising of Prescription Drugs

NCL has long been interested in ensuring that consumers receive accurate and useful information about their healthcare, including information about the safe and effective use of prescription drugs. With over four billion dollars spent a year on DTC ads [1] and over 91% of Americans reporting that they have seen or heard advertisements for prescription drugs[2], DTC ads have become an integral part of communicating information on prescription drugs. Consumers are continually exposed to these ads, and it is imperative that the FDA have the staff and resources to ensure the ads are accurate and not misleading BEFORE they reach the public.

As we have mentioned in previous testimony before the FDA, we recommend that the agency be granted the authority to require that all DTC ads undergo review before public dissemination. This would enable agency staff to work with industry to revise materials where needed so that misleading information does not reach consumers. Without the authority to make review a condition of broadcasting, product sponsors have no incentive to submit their ads for agency review. NCL urges the FDA to make the review of ads for newly approved drugs a top priority. FDA should consider placing a moratorium on all DTC advertising for new drugs, especially those deemed to have inadequate safety information. Based on available safety data, the agency could be given latitude in determining the appropriate length of the moratorium on a product-by-product basis. NCL would support adding a third “provisional” status for some new drugs, which would allow limited exposure of a product to appropriate patients. This would mitigate the likelihood of inappropriate use and over-exposure while additional post-approval safety data collection is ongoing.

In order to conduct such oversight of DTC advertising, we suggest that user fees be allocated to support hiring of additional staff to review ads and respond to industry feedback in a timely fashion. There is currently a dangerous imbalance between the volume of DTC advertising and the resources available for monitoring and reviewing the advertisements. This imbalance becomes even greater when considering the growing number of Internet and social media advertising for prescription drugs. As consumers increasingly turn to the Internet for health information, it will be more important than ever for FDA to have the resources to ensure that consumers receive balanced information about the drugs advertised to them

2. Adverse Event Reporting and Medwatch

Because reports of adverse events from consumers and healthcare professionals may be the first indication of a drug’s safety problem, it important that consumers are able to easily report any adverse events with medical products, and that FDA is able to capture and act upon that information. We are encouraged by the improvements that FDA is making to the Medwatch form for consumers. If FDA wants to encourage voluntary consumer reporting of adverse events, the Agency must ensure that reporting mechanisms are consumer-friendly. While we support FDA’s revisions of the Medwatch form, those revisions will fail to address the fact that the complaints entered into Medwatch are rarely used because of how the information is captured by the FDA. We understand that the information electronically collected on Medwatch is not able to be easily transferred to a usable electronic format so that any trends can be easily identified. The Medwatch system is not an active surveillance system; it is, in fact a passive program. We suggest that these issues be resolved so that Medwatch can effectively serve as an early warning system in a larger post-market safety surveillance system

3. Off-Label Prescribing

 

While off label use of medications can sometimes be beneficial, the majority of medications so prescribed have no valid scientific evidence in support of such prescribing.[3] A recent review by the Agency for Healthcare Research and Quality found that while antipsychotic drugs are used for many off label indications, for the majority of the medications there was little evidence of benefits, and in some cases there are serious adverse effects.[4] From a consumer perspective, many people are likely unaware they are even being prescribed off label drugs. Consumers should be informed about the following if they are prescribed drugs off label:

• Availability of alternatives

• Body of evidence supporting product use

• Approval status/use in other countries

• Implications for insurance coverage

Finally, we urge that under PDUFA V funds be directed to examining the safety of off- label prescribing, and the implications of lack of consumer awareness and understanding of the practice.

In conclusion, we believe the proposed recommendations must do more to ensure the safety of patient and consumers, and the scientific integrity of the drug review process. Thank you for giving the National Consumers League the opportunity to present our views on this important hearing related to the reauthorization of the Prescription Drug User Fee Act.

 

[1] Lian, Bryan, et al, “Direct to Consumer Advertising with Interactive Internet Media”, JAMA vol. 305, no. 8, February 23, 2011.

[2] Kaiser Public Opinion Spotlight, “Public and Physician Views on Direct-to-Consumers Prescription Drug Advertising” at https://www.kff.org/spotlight/rxdrugsconsumer/upload/Rx_Drugs_DTC_Ads.pdf

[3] Radley, et al. (2006) “Off-label Prescribing Among Office-Based Physicians,” Archives of Internal Medicine, 166: 1021-1026.

[4] AHRQ Effective Health Care Program, “Off-Label Use of Atypical Antipsychotics: An Update,” Comparative Effectiveness Review Number 43 (2011).