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NEW YORK, Jan. 11 /PRNewswire-FirstCall/ -- Instead of bringing consumers a sense of renewed optimism, the New Year brought a severe case of post-holiday blues which have taken a serious toll on consumer sentiment, according to the most recent results of the RBC CASH (Consumer Attitudes and Spending by Household) Index. Consumer confidence fell across the board and Americans' expectations for the future dipped into negative territory, according to the survey of 1,027 Americans taken earlier this week. As a result, the overall RBC CASH Index, released today by RBC, stands at 56.3 for January 2008, more than nine points below December's 65.9 level.
"The decline in the overall Index, to its lowest level since data collection began in 2002, highlights the impact that rising food and fuel costs and declining housing values are having on consumer confidence, said T. J. Marta, Economic and Fixed Income Strategist for RBC Capital Markets." With none of these headwinds likely to abate any time soon, consumers could pull back further on spending, increasing the risk of a recession.
The RBC CASH Index is a monthly national survey of consumer attitudes on the current and future state of local economies, personal finance situations, savings and confidence to make large investments. The Index is composed of four sub-indices: RBC Current Conditions Index; RBC Expectations Index; RBC Investment Index; and, RBC Jobs Index. The Index is benchmarked to a baseline of 100 assigned at its introduction in January 2002. This month's findings are based on a representative nationwide sample of 1,027 U.S. adults polled from January 7-9, 2008, by survey-based research company Ipsos Public Affairs. The margin of error was plus or minus 3.1 per cent.
Highlights of the survey results include:
- Consumers' economic outlook plummeted into negative territory during
the past month, as seen in the RBC Expectations Index, which reached
-8.2, compared to 7.9 in December. January's reading represents the
weakest level of optimism for future conditions since Hurricane
Katrina hit. The downturn in the index is being driven by expectations
that the economy as a whole will be weaker six months from now. Nearly
one in three Americans (27 per cent) believe that their local economy
will weaken in the coming months; currently, only one in five
consumers (19 per cent) believe their local economy will be stronger
six months from now.
- The RBC Current Conditions Index slid more than six points in January,
down to 78.9, compared to 85.3 in December. Worries over the current
state of the economy outweighed positive views, with one-third of
Americans (32 per cent) rating their local economy as weak,
considerably more than the 15 per cent who rate their local economy as
strong.
- Americans' dim view of their future prospects and current conditions
was mirrored in their outlook for making investments or major
purchases. The RBC Investment Index declined more than three points to
76.3 this month, compared to 79.7 in December. The shift in
consumers' investment confidence was driven by a decline in their
confidence in investing for the future. In January, only 33 per cent
of Americans reported they are more confident in their ability to
invest in the future, compared to 37 per cent last month. Confidence
in stock market dropped sharply as fewer than one-third (30 per cent)
of consumers indicated that the next month will be a good time to
invest in the stock market, down from 36 per cent in December.
- Americans' perception of job security dropped this month, but remains
relatively strong. The RBC Jobs Index for January stands at 106.9,
compared to 113.9 last month. Personal job loss experience increased
by four points this month, with 37 per cent of consumers reporting job
loss in their immediate circle, compared to 33 per cent in December.
In addition, only 32 per cent of Americans reported feeling more
confident about their job security, down four points from last month.
The entire RBC CASH Index report can be viewed at: www.rbc.com/newsroom/rbc-cash-index.html.
About RBC
RBC (RY on TSX and NYSE) is Canada's largest bank as measured by assets and market capitalization and one of North America's leading diversified financial services companies. In the United States, RBC provides personal and commercial banking, wealth management, insurance, corporate and investment banking and transaction processing services to about two million clients through RBC Centura, RBC Insurance, RBC Liberty Insurance, RBC Dain Rauscher and RBC Capital Markets. The company employs approximately 70,000 full- and part-time employees who serve more than 15 million personal, business, public sector and institutional clients throughout offices in North America and 36 countries around the world. For more information, please visit www.rbc.com.
Source: RBC Capital Markets
Findings Confirm Cautiously Optimistic Outlook in Seasonal Forecast
NEW YORK, Dec. 5 /PRNewswire/ -- Based on the findings of a new survey, Standard & Poor's Equity Research Services believes that American consumers' spending will grow during this Holiday season, albeit at a slower pace than seen over the past 10 years, despite their overall economic concerns. Conducted for Standard & Poor's Equity Research by InsightExpress, the survey focused on consumer spending and attitudes for the Holiday season within the current economic environment. Standard & Poor's Equity Research also believes the results support its 3.0% to 3.5% sales gain forecast in S&P Equity Research's 2007 Holiday Retail Outlook and Stock Picks, published by Standard & Poor's, a leading provider of financial market intelligence.
The majority of survey respondents did not show a significant decline in their intended holiday spending for 2007, as compared to 2006. Standard & Poor's Equity Research believes that this can be attributed to a strong job market and stable personal income outlook. Only 18% of respondents saw their personal financial situation worsening in the next six months. At the same time, while rising gas prices were of substantial concern, worries over job security were considerably lower.
"Despite a challenging economic environment, which many in our survey believe will worsen, the American consumer perseveres," notes Marie Driscoll, Director of the Consumer Discretionary-Retail Group for Standard & Poor's Equity Research Services. "Although our survey showed that housing concerns are weighing less than we expected on consumer minds, there is still reason for tempered optimism, especially as this may impact consumer confidence in 2008, along with rising fuel cost concerns. While Standard & Poor's believes that Holiday sales will be up modestly, we still stress investors take a cautious approach."
Standard & Poor's Equity Research Services' survey of consumer behavior and attitudes was conducted during November 2007 by InsightExpress. The survey sample consisted of 1,100 respondents throughout the U.S. to an online survey consisting of approximately 25 questions regarding their Holiday spending plans as well as their outlook in early 2008.
S&P Equity Research's 2007 Holiday Retail Outlook and Stock Picks was released in November 2007. The report examines the trends within the consumer discretionary retail industry for the Holiday season, and discusses the potential outcomes. Standard & Poor's Equity Research Services believes that retail sales will be weighed down by an array of economic concerns on consumers' minds, including continued housing weakness and high energy costs.
The report identifies many companies that have upside potential, along with stocks that may experience weak performance based on their current market position and exposure.
Retail analysts generally consider Christmas and Chanukah to be the biggest spending holidays, accounting for approximately 25% of GAFO (general merchandise, apparel, and other store) sales. S&P Economics sees GAFO sales rising 3% to 3.5% in the fourth quarter of 2007.
The analyst quoted above is a Standard & Poor's equity analyst. She has no affiliation with any company she covers, nor any ownership interest in any companies she covers.
Members of the media can request a copy of S&P Equity Research's 2007 Holiday Retail Outlook and Stock Picks by contacting Jeff Sexton at 212-438-3448, or via e-mail to jeff_sexton@standardandpoors.com.
About Standard & Poor's Equity Research Services
As the world's largest producer of independent equity research, Standard & Poor's licenses its research to over 1,000 institutions for their investors and advisors, including 19 of the top 20 securities firms, 13 of the top 20 banks, and 11 of the top 20 life insurance companies. Standard & Poor's team of 120 experienced U.S., European and Asian equity analysts use a fundamental, bottom-up approach to assess a global universe of approximately 2,000 equities across more than 120 industries worldwide. Follow Standard & Poor's equity analysts' U.S. market commentary each day at http://www.equityresearch.standardandpoors.com/.
The equity research reports and recommendations provided by Standard & Poor's Equity Research Services are performed separately from any other analytic activity of Standard & Poor's. Standard & Poor's Equity Research Services has no access to non-public information received by other units of Standard & Poor's. Standard & Poor's does not trade for its own account. The analytical and ethical conduct of Standard & Poor's equity analysts is governed by the firm's Research Objectivity Policy, a copy of which may also be found at www.standardandpoors.com or by clicking here.
About Standard & Poor's
Standard & Poor's, a division of The McGraw-Hill Companies (NYSE:MHP) , is the world's foremost provider of financial market intelligence, including independent credit ratings, indices, risk evaluation, investment research and data. With approximately 8,500 employees, including wholly owned affiliates, located in 22 countries, Standard & Poor's is an essential part of the world's financial infrastructure and has played a leading role for more than 140 years in providing investors with the independent benchmarks they need to feel more confident about their investment and financial decisions. For more information, visit http://www.standardandpoors.com/.
Source: Standard & Poor's
Web site: http://www.standardandpoors.com/
http://www.equityresearch.standardandpoors.com/
COSTA MESA, Calif., Aug. 7 /PRNewswire/ -- With millions of students getting ready to head back to school soon, the experts at NADAguides.com (http://www.nadaguides.com/) -- a leading vehicle pricing and information website -- today released tips to help teens, college-age students and parents navigate the back-to-school car buying process.
"Buying a car for a teenager or a young adult is a unique situation," said Don Christy, Jr., president and CEO, NADAguides.com. "Things like credit history, budget, safety and reliability play a large part in the car buying equation. These tips are designed as a guideline to assist students in finding the perfect vehicle, at the right price, to meet their needs."
1. Do your Homework
The car-buying process starts with homework to determine the type of vehicle that best fits your needs and your budget. In addition to determining whether you're buying new or used, you'll need to know the type of vehicle that's ideal for your own personal situation. For example, hybrid cars are great for commuters while four-wheel-drive SUVs, pick-up trucks and crossovers work well in all kinds of weather. There are also a variety of standard gas-powered compact cars that are economical, popular among younger car buyers and ideal for small parking spaces or crowded city driving.
NADAguides.com offers a side-by-side car comparison tool that allows students and their parents the ability to compare price, safety features, standard equipment and vehicle specifications for up to four different new and used makes, models and model years -- side-by-side, in real-time -- at the new car section of its website http://www.nadaguides.com/, for people who need help making the best car buying decision possible.
2. Check your Math
Next up, it's time to check your math. Start by researching the vehicle's retail price (if you're buying used) or MSRP (if you're buying new) at NADAguides.com to see if the vehicle fits within your budget, if the seller's asking price is fair, or if there are any incentives and rebates programs currently being offered that help offset the overall sales price -- you can research Current Offers at NADAguides.com to find out. Then, it's time to determine whether you'll pay cash or whether you'll need a loan. NADAguides.com offers an online car payment calculator, a free Credit Check service (so you know ahead of time exactly what your credit score is), online finance programs and detailed pricing information to help you evaluate the "math" involved with buying a car.
3. Complete your Paperwork
If you finance, there are a variety of lending companies (including financing at car dealerships) that specialize in loans for people with little or no credit. Be sure to factor in any down payments and trade-in allowances when determining what your overall monthly payment will be. Even though teenagers and young adults typically have little or no credit, parents or trusted family members can co-sign a loan to help a student qualify for financing they typically would not have qualified for on their own, while helping them establish a credit history in the process. Finally, review the documentation thoroughly to make sure you fully understand the terms of the financing, including the length of the loan, the interest rate and the overall amount of the monthly payment.
4. Buy an Apple (Not a Lemon)
If you're buying a used car -- either from an accredited dealer or a private party -- NADAguides.com suggests getting a Vehicle History Report, like the service offered at its website, to check whether the vehicle has suffered from frame damage, fire damage, water damage or from other problems in the past (such as a salvaged or damaged title or odometer rollback). "Even if the vehicle's history report comes back 'clean', it's still a good idea to solicit the help of a certified mechanic to inspect the vehicle prior to purchase, to ensure it's mechanically sound," said Christy.
5. Learn to be Safe
In addition to finding the right vehicle at the right price, NADAguides.com strongly urges teenagers and young adults to enroll in a driver safety program. "For most kids, buying and owning their first car is an enjoyable rite-of-passage," said Christy, "but safety should be the number one priority. We all want our kids to have fun, but above and beyond anything else, we want them to be safe in the process."
The editors at NADAguides.com have compiled a list of their favorite Back-to-School Vehicles for the Fall 2007 school year. Following is a list of their top picks in a variety of 'Who's Who' categories.
Best All Around 2007 Honda Civic Coupe, MSRP - $15,610
With its affordable price tag, cool styling, responsive handling, excellent fuel economy and solid safety ratings (as well as a wide range of aftermarket accessories and customization possibilities), this year's Honda Civic Coupe won Best All Around in the NADAguides.com Favorite Back-to-School Vehicles list.
Most Popular Among Girls 2007 Volkswagen New Beetle Convertible, MSRP - $22,240
The 2007 Volkswagen New Beetle Convertible was chosen as a NADAguides.com favorite among girls this school season, with its uniquely-rounded design, an enjoyable top-down driving experience and more than a dozen exterior and interior color configurations, including Sunflower Yellow.
Most Popular Among Guys 2007 Jeep Wrangler, MSRP - $18,610
Completely redesigned for 2007, the Jeep Wrangler boasts all the utility off-roaders could possibly want, with cool convertible driving thrown in. With a base 205 horsepower 3.8-liter V6, more-than-enough cargo room for plenty of skiing and school gear, locking differentials and off-road tires, the NADAguides.com editors chose it as a favorite among guys for the upcoming school season.
Most Likely to 'Play it Safe' 2007 Subaru Forester, MSRP - $21,195
The Subaru Forester offers ABS brakes, traction control, advanced driver and passenger-side airbags, rear seat head restraints and a five-star rating from the National Highway Traffic Safety Administration in frontal and side crash tests (as well as an affordable price tag compared to other comparably equipped, ultra-safe cars on the market) -- great news for students, as well as their safety-conscious parents.
Most Athletic 2007 Nissan Xterra, MSRP - $20,050
Available in 4WD, with excellent off-road features and towing capacity, the 2007 Nissan Xterra is equipped with a powerful base 4.0-liter V6 that generates 261 horsepower and 281 lb.-ft of torque, with passenger capacity for up to five and all their gear. Not only is the Xterra a tough little workhorse, it's geared towards a younger crowd, making it a top NADAguides.com Back-to-School Vehicle favorite.
Most Environmentally Conscious 2007 Toyota Prius, MSRP - $22,175
If it's fuel economy you want, there's nothing better than the 2007 Toyota Prius, with EPA estimates in the 60 City/41 Highway range -- a perfect car for long commutes to and from school. What's more, the Prius comes nicely equipped with plenty of amenities, including a navigation system and an AM/FM/CD/MP3 audio system, sure to please today's technically-savvy youth.
Best Dressed 2007 Ford Mustang, MSRP - $19,250
Since the beginning of its production life, the Ford Mustang has always been a fan favorite due in large part to its overall design, and the 2007 model year doesn't disappoint. With a base 210 horsepower 4.0-liter V6 and 240 lb.-ft of torque -- as well as throwback design cues reminiscent of classic Mustangs -- this year's model easily 'made the grade' as a NADAguides.com Favorite Back-to-School Vehicle pick.
Most Likely to Succeed 2007 Acura TSX, MSRP - $28,090
Even though the 2007 Acura TSX is considered an entry-level Sedan, there's nothing elementary about it. From heated leather lumbar seats to steering wheel audio controls, the Acura TSX is luxuriously equipped, safe and more affordably priced than comparably-equipped vehicles in its class. The TSX was designed for distinguished go-getters in mind -- kids on a fast track to the finer things (even though mom and dad will probably need to pick up the tab).
At NADAguides.com (http://www.nadaguides.com/), students can research pricing and specification information for virtually every new and used car on the market today, as well as side-by-side car comparisons, car buying and selling services, Vehicle History Reports, new and used car reviews and test drives, finance and insurance programs, Credit Check services and 360-degree new car interior and exterior photos, as well as a variety of new and used car buying tips -- for all the vehicles mentioned here and more.
About NADAguides.com
N.A.D.A. Appraisal Guides (NADAguides.com) is the world's largest publisher of vehicle pricing and specification information for new and used cars, trucks, vans, and SUVs, as well as van conversions, limousines, classic and collectible cars, boats, RVs, motorcycles, snowmobiles, personal watercraft and manufactured housing. The company's consumer website, NADAguides.com (http://www.nadaguides.com/), offers a variety of new and used vehicle services in addition to valuation information. Throughout its 74-year history, N.A.D.A. Appraisal Guides has earned the reputation as the recognized authority for vehicle valuations. Its website, NADAguides.com, is the most comprehensive vehicle information resource on the Internet today.
Source: NADAguides.com
Web site: http://www.nadaguides.com/
DALLAS, Aug. 9 /PRNewswire/ -- A new survey from market research firm Parks Associates has found that few consumers in the U.S. are satisfied with the videos they download from the Internet. Just 16% say the selection of videos available online is good, and only 13% say video downloads are sold at a reasonable price. Most tellingly, fewer than one in five consumers downloading video say they plan to download videos again in the future.
Consumers generally download video from one of two sources: peer-to-peer networks that offer unauthorized copies of TV programs and films, or licensed online services like iTunes. Low satisfaction levels might be expected for consumers using unlicensed sources because their quality and reliability are generally low-a consequence of being an unlicensed service. Yet even consumers who exclusively use legitimate services are unhappy with the experience (see figure below).
"People don't see a reason to use video downloading services," said John Barrett, director of research at Parks Associates. "Sure, it saves a trip to the video store, but it takes longer, looks worse, and you end up watching it on a 17" screen. No wonder consumers are dissatisfied with the experience." He noted that niche markets will emerge, but mainstream consumers will remain lukewarm about the video download experience. Good news for DVD makers, perhaps, but certainly not the feedback that online distributors like Apple are hoping to hear.
Global Digital Living(TM) II is a 13-country survey of international technology trends that included more than 13,000 respondents. For more information on this project, visit http://www.parksassociates.com/ or contact Parks Associates at 972-490-1113 or e-mail sales@parksassociates.com.
About Parks Associates
Parks Associates is an internationally recognized market research and consulting company specializing in emerging consumer technology products and services. Founded in 1986, Parks Associates creates research capital for companies ranging from Fortune 500 to small start-ups through market reports, primary studies, consumer research, custom research, workshops, executive conferences, and annual service subscriptions.
Each year, Parks Associates co-hosts executive thought leadership conferences CONNECTIONS(TM) and CONNECTIONS(TM) Europe in partnership with the Consumer Electronics Association (CEA(R)). In addition, Parks Associates produces the online publication Industry Insights in conjunction with the CONNECTIONS(TM) Conference series.
http://www.parksassociates.com/ http://www.connectionsconference.com/ http://www.connectionseurope.com/ http://www.connectionsindustryinsights.com/
Source: Parks Associates
Web site: http://www.parksassociates.com/
NEW YORK, June 15 /PRNewswire-FirstCall/ -- Colgate-Palmolive announced today additional developments and actions by the Company to protect consumers against possible risk from recently reported counterfeit toothpaste. The Company yesterday warned consumers that the counterfeit toothpaste, which has been found in some small, independent dollar-type discount stores, may not contain fluoride and could contain Diethylene Glycol, an ingredient not used in Colgate toothpaste anywhere in the world.
The additional developments and actions taken by the Company include:
-- Colgate is contacting all its accounts handling Colgate toothpaste in
the U.S. to ensure that they have no counterfeit product. At this time,
none have reported counterfeit product. If any accounts were to
identify suspected counterfeit product, the Company would remove it
from the shelf.
-- The Company is in the process of picking up suspected counterfeit
product in the small, independent dollar-type discount stores in the
four states where it has reportedly been distributed. Results of these
efforts will be provided to the U.S. Food and Drug Administration.
-- FDA spokesman Doug Arbesfeld was quoted in various news reports saying
in reference to the Diethylene Glycol found by the FDA in some
counterfeit samples, "It's a low health risk but the bottom line is, it
doesn't belong in toothpaste." Analysis performed by Colgate Research
& Development of counterfeit samples received so far has come to this
same conclusion regarding the low level of health risk.
-- The Company has further clarified the distinguishing characteristics of
the counterfeit product. It comes labeled as a 5 ounce or 100 ml tube,
a size not made or sold by Colgate in the United States. Consumers can
identify the counterfeit product by the words on the package,
"Manufactured in South Africa" as well as there may be several
misspelled words on the product carton including: "isclinically",
"SOUTH AFRLCA" and "South African Dental Assoxiation." Colgate does not
import toothpaste into the U.S. from South Africa.
-- Building on Colgate's long standing relationship with the American
Dental Association and American Dental Hygienists Association, the
Company will be providing information about the counterfeit product to
over 50,000 dental professionals to assist them in answering patient
questions.
-- Colgate is providing additional representatives on its consumer
information line (1-800-468-6502), extending their hours of operation,
adding operations this weekend, and taking other steps to answer
consumer questions about counterfeit product. Colgate is arranging for
callers to provide it with any suspect counterfeit products and
information about the purchase location.
Colgate Chairman and Chief Executive Officer Reuben Mark said, "We are all highly committed to reliability, quality and superior product performance. We will spare no effort to help consumers avoid counterfeits and support regulators in their efforts to remove these products from the marketplace."
About Colgate-Palmolive: Colgate-Palmolive is a leading global consumer products Company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, Mennen, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, Elmex, Tom's of Maine, Ajax, Axion, Soupline, and Suavitel, as well as Hill's Science Diet and Hill's Prescription Diet. For more information about Colgate's global business, visit the Company's web site at http://www.colgate.com/.
This press release may contain forward-looking statements. Such statements may relate, for example, to sales or volume growth, profit growth, earnings growth, financial goals, cost-reduction plans, estimated charges and savings associated with the 2004 Restructuring Program and new product introductions. These statements are made on the basis of our views and assumptions as of this time and we undertake no obligation to update these statements. We caution investors that any such forward-looking statements are not guarantees of future performance and that actual events or results may differ materially from those statements. Investors should consult the Company's filings with the Securities and Exchange Commission (including the information set forth under the caption "Risk Factors" in the Company's Form 10-K for the year ended December 31, 2006) for information about factors that could cause such differences. Copies of these filings may be obtained upon request from the Company's Investor Relations Department or the Company's web site at http://www.colgate.com/.
Source: Colgate-Palmolive
Web site: http://www.colgate.com/
NEW YORK, June 14, 2007 /PRNewswire-FirstCall/ -- The Colgate-Palmolive Company today warned that counterfeit toothpaste falsely packaged as "Colgate" has been found in several dollar-type discount stores in four states: New York, New Jersey, Pennsylvania and Maryland. There are indications that this product does not contain fluoride and may contain Diethylene Glycol. The Company stated that it does not use, nor has ever used, Diethylene Glycol as an ingredient in Colgate toothpaste anywhere in the world.
The counterfeit toothpaste can be easily recognized because it is labelled as "Manufactured in South Africa." Colgate does not import toothpaste into the United States from South Africa. In addition, the counterfeit packages examined so far have several misspellings including: "isclinically", "SOUTH AFRLCA" and "South African Dental Assoxiation."
Counterfeit toothpaste is not manufactured or distributed by Colgate and has no connection with the Company whatsoever. Colgate is working closely with the US FDA to help to identify those responsible for the counterfeit product.
Consumers who suspect they may have purchased counterfeit product, can call Colgate's toll-free number at 1 800 468 6502.
About Colgate-Palmolive: Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, Mennen, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, Elmex, Tom's of Maine, Ajax, Axion, Soupline, and Suavitel, as well as Hill's Science Diet and Hill's Prescription Diet. For more information about Colgate's global business, visit the Company's web site at http://www.colgate.com/.
This press release may contain forward-looking statements. Such statements may relate, for example, to sales or volume growth, profit growth, earnings growth, financial goals, cost-reduction plans, estimated charges and savings associated with the 2004 Restructuring Program and new product introductions. These statements are made on the basis of our views and assumptions as of this time and we undertake no obligation to update these statements. We caution investors that any such forward-looking statements are not guarantees of future performance and that actual events or results may differ materially from those statements. Investors should consult the Company's filings with the Securities and Exchange Commission (including the information set forth under the caption "Risk Factors" in the Company's Form 10-K for the year ended December 31, 2006) for information about factors that could cause such differences. Copies of these filings may be obtained upon request from the Company's Investor Relations Department or the Company's web site at http://www.colgate.com/.
Source: Colgate-Palmolive
Web site: http://www.colgate.com/
WASHINGTON, June 21 /PRNewswire-USNewswire/ -- The House Energy and Commerce Committee Thursday overwhelmingly passed a major package of prescription drug safety reforms -- including requiring the drug industry to contribute almost $400 million over five years to improve safety measures and to register most of their clinical trial studies so the public can know more about potential harmful drug side effects.
The committee, led by Chairman John Dingell and Health Chairman Frank Pallone, approved amendments to require the FDA reach certain safety goals with industry user fees and make public transcripts of negotiations between industry and the FDA. The panel also was in agreement to increase the fines on companies that run false or misleading drug advertisements.
The panel beat back attempts to weaken the legislation on conflicts of interest on drug advisory boards and clinical trial results requirements.
"There is no question the drug industry is putting huge pressure on Congress to weaken these important patient-safety reforms," said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. "So many members worked tirelessly for this strong legislation, and their efforts will be counted in the number of lives saved by more quickly and publicly dealing with drug safety risks."
The House bill gives the FDA power to change drug labels and require companies conduct further safety studies once they are on the market. It also requires drug makers to register most of their clinical trials; details on how results will be made public are still being worked out.
"The committee appears to have stood firm and made sure drug companies can't downplay or hide the safety risk information that often comes out of these clinical studies," Vaughan said.
Like the Senate bill passed last month, the House measure includes almost $400 million in user fees on the industry over the next five years to fund drug safety measures, including mining large health databases to spot those drugs that might cause health problems.
But the House bill included some measures that expanded drug safety beyond the Senate, including:
-- Limiting conflicts of interest waivers on drug advisory committees to
one per panel. Currently, the panels that recommend drugs for market
often include several members with financial ties to the company whose
drug is up for approval, and the FDA routinely waives the conflict
laws. The Senate bill did not limit the number of waivers.
-- An amendment by Rep. Stupak directing that safety funds be spent to
aggressively use the data collected by the adverse event reporting
system, make public any office of drug safety consultations with the
Office of New Drugs so that consumers and outside researchers can see
where areas of controversy are, and cleaning up the backlog of hundreds
of unstarted clinical trials.
-- Requiring all direct-to-consumer advertisements carry an 800-number and
Web site address where consumers could report adverse reactions to
drugs to the FDA.
-- Allowing consumer and patient members to be involved in the next round
of negotiations between the drug industry and the FDA on how user fees
should be collected and spent to approve new drugs. An amendment by
Rep. Stupak was also approved today requiring a public transcript of
the negotiations, which currently are held behind closed doors.
-- Providing somewhat more meaningful penalties for violations of FDA
safety laws. The House Civil Monetary Penalties and penalties for
repeated false and misleading ads are higher than the Senate's and are
more likely to ensure compliance.
-- Requires a review of the safety of a drug in the 7th year after it has
been approved; since on average only half of all adverse events are
known by the 7th year, this provision forces a review of the benefits
and risks of a drug at a time when more is known about it.
-- Ensure that any health databases used to look for drug safety problems
de-identify patient's personal information.
"We look forward to the full House passing this important drug safety legislation, and moving it on to conference and then the President's desk," Vaughan said.
Source: Consumers Union
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