If you make less than $1MM a year, keep reading. If you make more, kudos to you. You can sit back and laugh at this posting.

Recall, the pundits cried..."The markets will be the common man's buddy...". Ha, ha. 401K accounts are down 40% or more, executive retirement accounts are up 8% +. Why is that? I'll let my readers ponder. Ok. You've pondered. It's because execs get GUARANTEED returns!!! Do you, loyal company woman?

Wall Street assured the "public" that it was on their side. What Wall Street really wanted was for Americans to not understand that Wall Street was not exactly squaring with them!

What happened next? Americans began to "believe" that the regulators, thanks to President Bush, were sabotaging their lives. What was really happening in their lives is that the regulators were ignoring their lives!

So, should any of us question the INCREDIBLE class differences that are now so obvious in this country?

Question: Should we continue to believe that Wall Street has our best interests at heart? Or should all Americans wake up and smell the coffee that Wall Street looks after Wall Street and Main Street should look after Main Street? I should hope so.

“The mission of the Cato Institute is to increase the understanding of public policies based on the principles of limited government, free markets, individual liberty, and peace.  The Institute will use the most effective means to originate, advocate, promote, and disseminate applicable policy proposals that create free, open, and civil societies in the United States and throughout the world.”

Parse those words carefully, you’ll see the familiar code words for conservative causes, in spite of the Institute’s website description which describes the Cato Institute as Libertarian Capitalism, whatever that means. But who cares, in a new study by Peter Dixon and Maureen Rimmer at the Cato Institute, the findings are much like the findings in my book Hispanic Heresy.  The findings throw cold water on the red-blooded Americans who typically back conservative causes and talk show hosts like Lou Dobbs, Bill O’Reilly, Glenn Beck, and Sean Hannity, etc.  Those shows and their audiences typically scream at the top of their lungs that we need to immediately deport 12 illegal aliens.

Little Information Given About Solo Law Practice Run by Sotomayor in '80s
The New York Times
By SERGE F. KOVALESKI
Published: July 6, 2009
 
Since Sonia Sotomayor was nominated for a seat on the United States Supreme Court, her career and accomplishments have come to light in public and voluminous fashion.

Skip to next paragraphHer Senate questionnaire lists dozens of her awards and honors, her letters to the editor of her college newspaper, her speeches and cases she handled as a prosecutor, a lawyer in private practice and, for the last 17 years, as a federal judge.

Yet as she moves through the confirmation process, Judge Sotomayor has explained very little about one facet of her legal life: Sotomayor & Associates, the solo law practice she ran out of her Brooklyn apartment for several years in the 1980s.

In her questionnaire, Judge Sotomayor says she was the "owner" of Sotomayor & Associates, which she described as a consulting business she operated on the side from 1983 to 1986. During this period, she also worked, first for the Manhattan district attorney's office and then as a member of Pavia & Harcourt, a large firm in Manhattan.

As a single practitioner, she told the Senate, she had helped "family and friends in their real estate, business and estate planning decisions." The only other thing she has said about the practice is that if her clients "required more substantial legal representation, I referred the matter to my firm, Pavia & Harcourt, or to others with appropriate expertise."

The White House has described Ms. Sotomayor's outside legal work as an informal practice, one that never required her to file legal documents or appear in court. She never incorporated Sotomayor & Associates or registered it as a business in Manhattan or Brooklyn, where she then lived, according to public records, though she was not required to do so.

Associates in the district attorney's office and George M. Pavia, the senior partner of Pavia & Harcourt, said they did not recall that she had done outside legal work at the time. "It is news to me," Mr. Pavia said. He said she likely cleared the outside work with her direct supervisor, who is now dead.

At the time she began her legal consulting work, Ms. Sotomayor was an assistant district attorney, going through a divorce and earning about half of what lawyers in private practice made.

White House communications officials said the judge no longer had copies of the tax returns that listed the income, and any deductions, that she attributed to her outside work. A White House spokeswoman said at one point that because of the considerable passage of time, Judge Sotomayor could not estimate how many people she had counseled or remember their names.

The White House later provided names of three clients: an independent insurance salesman, no longer alive, for whom she helped review contracts; a cousin for whom she prepared a divorce — although the filing came a few years after the judge said she had stopped her outside work — and a friend who sought help setting up his dry cleaning business. The friend, Ken Kinzer, is married to one of the judge's close friends, Dawn Cardi. Ms. Cardi, a lawyer, said initially that she did not recall the judge operating an outside legal practice. But Ms. Cardi said she subsequently remembered her friend's assistance, and recalled that she gave her a pocketbook in appreciation.

Ms. Sotomayor's outside work was approved, she said through a spokesman, by the Manhattan district attorney's office, which has a policy that governs such work. Although the White House said Judge Sotomayor earned income in 1983, a spokeswoman for the district attorney's office, Alicia Maxey Greene, initially said that the office did not allow prosecutors to charge for outside work. Generally, they were only allowed to help friends and family for free on a case-by-case basis.

Several former members of the office said they remembered the policy as being quite clear. "We were expressly prohibited from having a law practice on the side," said Katharine Law, a friend of the judge who worked with her at the time.

But District Attorney Robert M. Morgenthau said subsequently that his spokeswoman had been wrong and that the office had been quite liberal at the time in approving outside work by staff, even if they charged fees.

The judge's choice of the name Sotomayor & Associates is regarded by some legal ethicists as a confusing departure for someone generally regarded as meticulous about preparation and following the rules.

Stephen Gillers, professor of legal ethics at New York University Law School, said Judge Sotomayor's use of the larger-sounding title was "inadvisable because it is inaccurate." He noted that bar associations frown on the use of the term "and associates" by single practitioners. "She could have just said, 'Law Offices of Sonia Sotomayor,' " he said.

Bar associations have held that the use of such a name can be misleading. But Mr. Gillers said that since Ms. Sotomayor never appears to have advertised or to have put the name on letterhead, it is a technical issue and not one likely to ever have been cited by a disciplinary committee in the New York State court system. But he said that if the panel had received a complaint about the name, it would have required her to change it.

White House officials disagreed that the use of the name was a misstep, and they offered a written analysis by Hal R. Lieberman, a former disciplinary committee chief counsel in New York.

"Neither bar opinions nor cases to date have held that it was misleading for a sole practitioner to use the name 'and Associates' in such private communications," he wrote in an e-mail message. "In fact, in the early 1980s, no rule prohibited the use of 'and Associates' in these circumstances and the only authority regarding the use of 'and Associates' in an advertising context was advisory, not mandatory, and thus not readily enforceable."

A White House spokesman, Ben LaBolt, said, "All of the clients were well aware of the limited services Judge Sotomayor could provide given the other positions she held."

Mr. LaBolt said that Ms. Sotomayor came up with the name when she was filling out her tax returns. "It was necessary to list a name for the practice on her tax returns," he said.

Tax experts say there was nothing in the law that requires a lawyer, or any other self-employed person, to create a corporate name to report income, or deductions, on the standard form, known as a Schedule C. Just one's own name will do. But Mr. LaBolt pointed out that the 1983 copy of the form asked the filer to list his or her "business name."

"Significant time was not spent in choosing a name," he said.
 
Her Senate questionnaire lists dozens of her awards and honors, her letters to the editor of her college newspaper, her speeches and cases she handled as a prosecutor, a lawyer in private practice and, for the last 17 years, as a federal judge.

Yet as she moves through the confirmation process, Judge Sotomayor has explained very little about one facet of her legal life: Sotomayor & Associates, the solo law practice she ran out of her Brooklyn apartment for several years in the 1980s.

In her questionnaire, Judge Sotomayor says she was the "owner" of Sotomayor & Associates, which she described as a consulting business she operated on the side from 1983 to 1986. During this period, she also worked, first for the Manhattan district attorney's office and then as a member of Pavia & Harcourt, a large firm in Manhattan.

As a single practitioner, she told the Senate, she had helped "family and friends in their real estate, business and estate planning decisions." The only other thing she has said about the practice is that if her clients "required more substantial legal representation, I referred the matter to my firm, Pavia & Harcourt, or to others with appropriate expertise."

The White House has described Ms. Sotomayor's outside legal work as an informal practice, one that never required her to file legal documents or appear in court. She never incorporated Sotomayor & Associates or registered it as a business in Manhattan or Brooklyn, where she then lived, according to public records, though she was not required to do so.

Associates in the district attorney's office and George M. Pavia, the senior partner of Pavia & Harcourt, said they did not recall that she had done outside legal work at the time. "It is news to me," Mr. Pavia said. He said she likely cleared the outside work with her direct supervisor, who is now dead.

At the time she began her legal consulting work, Ms. Sotomayor was an assistant district attorney, going through a divorce and earning about half of what lawyers in private practice made.

White House communications officials said the judge no longer had copies of the tax returns that listed the income, and any deductions, that she attributed to her outside work. A White House spokeswoman said at one point that because of the considerable passage of time, Judge Sotomayor could not estimate how many people she had counseled or remember their names.

The White House later provided names of three clients: an independent insurance salesman, no longer alive, for whom she helped review contracts; a cousin for whom she prepared a divorce — although the filing came a few years after the judge said she had stopped her outside work — and a friend who sought help setting up his dry cleaning business. The friend, Ken Kinzer, is married to one of the judge's close friends, Dawn Cardi. Ms. Cardi, a lawyer, said initially that she did not recall the judge operating an outside legal practice. But Ms. Cardi said she subsequently remembered her friend's assistance, and recalled that she gave her a pocketbook in appreciation.

Ms. Sotomayor's outside work was approved, she said through a spokesman, by the Manhattan district attorney's office, which has a policy that governs such work. Although the White House said Judge Sotomayor earned income in 1983, a spokeswoman for the district attorney's office, Alicia Maxey Greene, initially said that the office did not allow prosecutors to charge for outside work. Generally, they were only allowed to help friends and family for free on a case-by-case basis.

Several former members of the office said they remembered the policy as being quite clear. "We were expressly prohibited from having a law practice on the side," said Katharine Law, a friend of the judge who worked with her at the time.

But District Attorney Robert M. Morgenthau said subsequently that his spokeswoman had been wrong and that the office had been quite liberal at the time in approving outside work by staff, even if they charged fees.

The judge's choice of the name Sotomayor & Associates is regarded by some legal ethicists as a confusing departure for someone generally regarded as meticulous about preparation and following the rules.

Stephen Gillers, professor of legal ethics at New York University Law School, said Judge Sotomayor's use of the larger-sounding title was "inadvisable because it is inaccurate." He noted that bar associations frown on the use of the term "and associates" by single practitioners. "She could have just said, 'Law Offices of Sonia Sotomayor,' " he said.

Bar associations have held that the use of such a name can be misleading. But Mr. Gillers said that since Ms. Sotomayor never appears to have advertised or to have put the name on letterhead, it is a technical issue and not one likely to ever have been cited by a disciplinary committee in the New York State court system. But he said that if the panel had received a complaint about the name, it would have required her to change it.

White House officials disagreed that the use of the name was a misstep, and they offered a written analysis by Hal R. Lieberman, a former disciplinary committee chief counsel in New York.

"Neither bar opinions nor cases to date have held that it was misleading for a sole practitioner to use the name 'and Associates' in such private communications," he wrote in an e-mail message. "In fact, in the early 1980s, no rule prohibited the use of 'and Associates' in these circumstances and the only authority regarding the use of 'and Associates' in an advertising context was advisory, not mandatory, and thus not readily enforceable."

A White House spokesman, Ben LaBolt, said, "All of the clients were well aware of the limited services Judge Sotomayor could provide given the other positions she held."

Mr. LaBolt said that Ms. Sotomayor came up with the name when she was filling out her tax returns. "It was necessary to list a name for the practice on her tax returns," he said.

Tax experts say there was nothing in the law that requires a lawyer, or any other self-employed person, to create a corporate name to report income, or deductions, on the standard form, known as a Schedule C. Just one's own name will do. But Mr. LaBolt pointed out that the 1983 copy of the form asked the filer to list his or her "business name."

"Significant time was not spent in choosing a name," he said.

©2009 Angel Reyes
www.ReyesLaw.com

Justice Souter Departs
New York Times 5/2/09 - Editorial

When President George H. W. Bush nominated him to the Supreme Court in 1990, David Souter was an obscure New Hampshire judge with a thin paper trail, hard to figure out, and supporters of civil liberties, civil rights and abortion rights worried that he was being put on the court to do damage to their causes.

Senator Edward M. Kennedy, Democrat of Massachusetts, said Judge Souter had failed to show “abiding commitment” to “core constitutional values.” He and other liberal senators voted against confirmation.

How wrong Senator Kennedy, and almost everyone else, was. Abiding commitment to core constitutional values is precisely what Justice Souter — who has decided to retire — has demonstrated in his 18 years on the court. To the relief of liberals and the dismay of conservatives — who have made “No More Souters!” a judicial-nomination rallying cry — Justice Souter turned out to be nothing like what anyone expected.

The first opinion he wrote overturned, for a unanimous court, the conviction of a black man for killing a white woman, because the defendant had not been given ample opportunity to challenge the makeup of the nearly all-white Georgia jury. Justice Souter went on to become a reliable champion of civil rights. In 2003, he provided a critical fifth vote upholding the University of Michigan’s affirmative action program.

He has also been a firm supporter of the constitutional right to abortion. In 1992, in Planned Parenthood v. Casey, he voted to uphold the court’s embattled ruling in Roe v. Wade.

After Sept. 11, Justice Souter backed the due-process rights of the prisoners being held in Guantánamo Bay. He has voted in favor of gay rights, and carefully tended the line between church and state.

One of Justice Souter’s finest moments came in Bush v. Gore. He did not look at the case through the prism of his Republican politics, or of personal loyalty; one of the parties was, after all, the son of the man who put him on the court. Instead, he rightly insisted — in dissent, of course — that Florida should be allowed to continue counting votes.

Before he decided to step down at the end of this term, Justice Souter often spoke, with evident sincerity, of missing his simpler life in New Hampshire. He may simply have been waiting for a like-minded president whom he would feel comfortable seeing fill his seat.

Furious speculation has already begun over who will do that. President Obama, a onetime professor of constitutional law, will bring considerable legal knowledge and insight to the choice. One of the best guideposts he could use is to look for someone who has demonstrated the same character, intellectual rigor and commitment to core constitutional values as the man giving up the seat.

©2009 Angel Reyes
www.ReyesLaw.com

Panama to Signal Obama's Agenda
Wall Street Journal
APRIL 28, 2009
By GREG HITT

WASHINGTON -- President Barack Obama has signaled in recent days a more positive stance toward free trade than he did on the campaign trail, pleasing business groups but courting a backlash among trade-skeptical Democrats in Congress.

©2009 Angel Reyes
www.ReyesLaw.com

I have personally met with Ann on several occasions and have known of her community involvement and work in and around Dallas. I thoroughly believe she will be a wonderful addition to the City Council and will be well respected among her colleagues and peers.

Ann's resume is quite impressive - her business experience as the founding partner of a general insurance agency (where she oversaw agents in 23 states), together with her experience in her own investment real estate company provide her with the necessary background and experience to help the City of Dallas remain fiscally responsible and viable.

Ann has tremendous voluntary experience on numerous public and non-profit boards in addition to those boards mentioned already (i.e., the Dallas Park and Recreation Board, Dallas City Plan Commission, and Parkland Memorial Hospital) such as the Safer Dallas Better Dallas Board, World Affairs Council, Southwestern Medical Foundation, Parkland Foundation, Zale Lipshy University Hospital, North Dallas Chamber of Commerce, Temple Emanuel,  Texas Woman's University Business School and several others.

Ann has lived in Dallas for more than 30 years and has lived in District 13 for more than 25 years. No doubt, she will bring her varied background and wise business acumen to the Council and be a tremendous asset to our great city. That’s why the Dallas Hispanic Political Action Committee supports Ann Margolin for City Council, District 13 and I’m proud to say that I personally endorse this outstanding candidate.

©2009 Angel Reyes
www.ReyesLaw.com

No Legal Shield in Drug Labeling, Justices Rule
The New York times
By ADAM LIPTAK
Published: March 4, 2009

WASHINGTON — In a major setback for business groups that had hoped to build a barrier against injury lawsuits seeking billions of dollars, the Supreme Court on Wednesday said state juries may award damages for harm from unsafe drugs even though their manufacturers had satisfied federal regulators.

The ruling could have significant implications beyond drug manufacturing. Many companies have sought tighter federal regulation in recent years in part to shield themselves from litigation.

The court, by a 6-to-3 vote, upheld a jury verdict of $6.7 million in favor of a musician from Vermont whose arm had to be amputated after she was injected with an anti-nausea drug. The drug’s manufacturer, Wyeth, had argued that its compliance with the Food and Drug Administration’s labeling requirements should immunize it from lawsuits.

Pharmaceutical companies were especially disappointed by Wednesday’s decision.

Ronald Rogers, a spokesman for Merck, said, “We believe state courts should not be second-guessing the doctors and scientists at the F.D.A.”

Merck was hit with several huge damage awards over its painkiller Vioxx before agreeing to a $4.85 billion settlement in 2007. Allowing juries to make determinations about drug risks, Mr. Rogers said, would cause “mass confusion.”

The Supreme Court has been sympathetic in recent years to arguments that federal law should pre-empt state injury suits. Last year, in Riegel v. Medtronic, an eight-justice majority of the court ruled that many state suits concerning injuries caused by medical devices were barred by the express language in a federal law. Wednesday’s decision addressed implied pre-emption, a different legal standard.

Drug companies and other businesses, supported by the Bush administration, had hoped the Vermont case would establish broader protections. They relied not on express language in a statute enacted by Congress, as in Riegel, but on what might be implied from federal regulatory standards and policies — in this case, from the drug agency’s authority to approve drug labels.

Producers of goods as different as antifreeze, fireworks, popcorn, cigarettes and light bulbs have sought to take refuge behind federal oversight in recent years to fend off litigation. After Wednesday’s decision, those efforts are most likely to succeed if they are based on express language in a Congressional statute or a specific regulatory action that makes compliance with state requirements impossible.

“This narrows the playing field,” for implied pre-emption arguments, Mark Herrmann, a corporate defense lawyer in Chicago, said of the decision. “This does not eliminate the playing field.”

Most drug company stocks, including Wyeth’s, closed up on Wednesday, as did the Dow Jones industrial average, which rose 150 points, breaking a long losing streak.

Catherine M. Sharkey, a law professor at New York University, said the decision does mean that “there is certainly a thumb on the scale against the more aggressive arguments for implied pre-emption.”

Justice John Paul Stevens, writing for the majority in Wednesday’s decision, Wyeth v. Levine, No. 06-1249, said Congress could have required pre-emption in the case but had not. “Evidently,” he said, “it determined that widely available state rights of action provided appropriate relief for injured consumers.”

Justice Stevens noted that Congress did adopt just such an express pre-emption provision for medical devices in the law at issue in the Riegel case.

Until a recent change in policy under the Bush administration, Justice Stevens wrote, the drug agency had welcomed state injury suits as a useful complement to federal regulation. But in “a dramatic change in position” in 2006, Justice Stevens said, the agency reversed that longstanding policy not withstanding its “limited resources to monitor the 11,000 drugs on the market.”

The agency’s new position, Justice Stevens wrote, “is entitled to no weight.” He was similarly dismissive of a brief supporting Wyeth filed by the Justice Department under former President George W. Bush, saying it was “undeserving of deference.”

Justice Stevens was joined by Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Stephen G. Breyer. Justice Clarence Thomas voted with the majority but did not adopt Justice Stevens’s reasoning, saying instead that he objected generally to “far-reaching implied pre-emption doctrines” that “wander far from the statutory text.”

Justice Samuel A. Alito Jr., writing for the three dissenters, said the court had done an about-face, “turning yesterday’s dissent into today’s majority opinion” and turning ordinary injury suits into a “frontal assault on the F.D.A.’s regulatory regime for drug labeling.”

“This case illustrates,” Justice Alito said, “that tragic facts make bad law.”

The case began in 2000, when Diana Levine, suffering from migraine headaches, visited a clinic. She was given injections of Demerol for the pain and Wyeth’s drug Phenergan for nausea.

If Phenergan is exposed to arterial blood, it can cause swift and irreversible gangrene. For that reason, it is usually administered by intramuscular injection or intravenous drip. This time, a physician’s assistant used a third method, injecting the drug into what she thought was a vein, a method known as “IV push.”

In the following weeks, Ms. Levine’s hand and forearm turned black, and they were amputated in two stages. She settled a lawsuit against the clinic and went to trial against Wyeth, claiming its warnings against IV-push administration were not strong enough.

She greeted Wednesday’s decision with elation. “Next to getting my hand back,” she said of the Supreme Court, “it’s the least they could have done and the best they could have done.”

Bert Rein, a lawyer for Wyeth, said the company had “fully complied with federal law in its labeling of Phenergan,” adding that the F.D.A. is “in the best position to weigh the risks and benefits of a medicine.”

Justice Alito said Wyeth had provided ample notice about the risk of gangrene in “six separate warnings,” some of them “in boldfaced font and all-capital letters,” on the drug label the F.D.A. had approved.

Justice Alito, writing for himself, Chief Justice John G. Roberts and Justice Antonin Scalia, added that juries see only the “tragic accident” before them and “are ill-equipped to perform the F.D.A.’s cost-benefit-balancing function.” The agency, by contrast, he wrote, “has the benefit of the long view” and “conveys its warnings with one voice.”

“After today’s ruling,” he said, “parochialism may prevail.”

Click here to download a PDF of the actual Supreme Court Opinion in its entirety.

©2009 Angel Reyes
www.ReyesLaw.com

Dallas lawyer Angel L. Reyes III says policy makers need to start thinking about how the immigration of Hispanics to the United States impacts socio-economics. So Reyes and two business professors at Texas Tech University wrote a book on that topic published in December 2008.

What’s Behind an F.D.A. Stamp?
By GARDINER HARRIS
The New York Times
Published: September 29, 2008

The F.D.A. is everywhere these days, or so it seems.

Sellers of dubious medical devices claim in late-night TV advertisements that their products are “registered with the F.D.A.”

Some vitamins and homeopathic remedies, many with doubtful benefits, boast on their labels that they are “F.D.A. approved.”

In the 1990s, the agency was widely criticized as taking too long to approve new drugs, so Congress passed legislation speeding up drug reviews.

Then in 2004, Merck withdrew its painkiller Vioxx after studies showed the pill increased the risk of heart attacks and strokes.

Critics lambasted the agency, saying it approved medicines too easily and for months delayed issuing warnings about potential drug risks.

The agency now issues a blizzard of risk alerts, but sifting through this information can be difficult. And it can be tough to figure out which products have the agency’s crucial stamp of approval — or what bits of product information have actually been vetted by federal regulators.

For instance, the drug information sheets that pharmacists routinely give to patients along with their prescription medicines — the sheets are sometimes printed on receipt paper — seem like official government pronouncements.

But the F.D.A. has no role in writing or overseeing most of these sheets. Public Citizen, a watchdog group, has found that some drug information sheets are dangerously wrong or misleading.

What is a consumer to do?

The F.D.A. is the federal agency charged with overseeing the safety of drugs, medical devices, food, cosmetics and many other health-related products. But although the agency has regulatory authority over nearly 25 percent of the nation’s economy, it is important to understand what it regulates closely and what it doesn’t.

For example, the F.D.A. does almost nothing to ensure that dietary supplements work as advertised. Only when supplements are proved to be unsafe or to contain regulated substances can the agency take action.

In the past year, the agency has seized thousands of Asian herbal supplements promoting virility because they contained the active ingredient in Viagra, a regulated substance. Similarly, the F.D.A. exempts over-the-counter homeopathic remedies from its testing. So any reference to the F.D.A. on dietary supplements or homeopathic medicines generally does not mean that the agency has found the products to be safe or effective.

And the sellers of quasi-medical devices or food products that claim their products are “registered” with the F.D.A. may have done little more than send a letter to the agency. The Bioterror Act of 2002 requires food manufacturers to register with the F.D.A., but the agency almost never inspects these facilities or products.

For drugs, the F.D.A.’s role is more complicated. In most cases, the F.D.A. demands that manufacturers seeking to sell drugs in the United States, either over the counter or prescription, prove that they’re safe and effective. But there are exceptions, and these can be hard to spot.

A surprising number of older prescription medicines have been around for so long that they have never been vetted by the agency. Officials have promised for decades that they would catch up with these products. But dozens, perhaps hundreds, still remain.

Just last year, the F.D.A. announced that it would force off the market many unapproved products containing hydrocodone, a popular and addictive narcotic often used as a cough suppressant. Many of these products had not been inspected or approved by the agency, and some had labels stating they could be used in children as young as 2, although such products had never been approved for use in preschool children.

Even some products with F.D.A. approval have very little evidence that they work. For instance, when the F.D.A. approved over-the-counter pediatric cold and cough remedies decades ago, its standards were far lower than they are today. Some of the medicines in these products have never proved effective in children, and children have, in rare cases, been harmed by them. The agency is in the midst of a years-long process that could revoke approval of many pediatric cough medicines.

The most challenging situation facing the F.D.A. and consumers is the growing number of reports of adverse reactions to popular medicines. The agency received nearly 500,000 such reports last year, but most were false alarms. Figuring out which signal real safety issues is difficult.

In the past the agency typically said little or nothing about its suspicions of safety issues until top officials concluded that they were real. But several years ago, a midlevel drug safety officer concluded in a report that studies of antidepressants showed that the drugs caused an increase in suicidal behaviors or thoughts in children and teenagers. Top officials suppressed the report and refused to allow the official to testify before an expert committee. A year later, a more thorough study confirmed the risk. When news of the earlier report leaked, the agency was severely criticized.

Top agency officials promised to be more open about potential drug risks. The F.D.A. has sent out public health advisories about potential drug problems and created a consumer information Web site. And under prodding from Congress, it even created a quarterly list of potential drug problems that safety reviewers are in the midst of investigating.

However, a drug’s appearance on the list does not mean that the F.D.A. has concluded that the medicine is particularly risky. Rather, it shows that safety officials have some reason to suspect a problem.

“If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently,” said Janet Woodcock, director of the agency’s drug center.

Recently, the F.D.A. has mandated that pharmacists dispense consumer guides with some drugs that explicitly detail medicines’ risks. These guides, written by the F.D.A., are often far more comprehensive than the drug information sheets traditionally given by pharmacists.
Safety advocates have been pleased. “Our position is that medication guides should be provided for all drugs, period,” said Dr. Peter Lurie, deputy director of the health research group at Public Citizen.

©2008 Angel Reyes
www.ReyesLaw.com

Product-Safety Bill Emerges in Congress
Wall Street Journal
July 29, 2008 7:08 a.m.

House and Senate negotiators late yesterday reached a deal for a ban on certain toxins found in toys and a strengthening of the government's ability to police consumer products, a blow to the chemicals industry following a series of high-profile recalls and health warnings.

The bill, which has Democratic and Republican support, would outlaw all but minute amounts of lead in children's products and ban from toys and other objects meant for children the ubiquitous family of chemicals known as phthalates. It would also require third-party testing of some children's products and bolsters the Consumer Product Safety Commission's authority to inspect manufacturers' labs. The bill "would have significant implications for U.S. consumers, whose homes are filled with hundreds of plastic products designed for children that may be causing dangerous health effects," the Washington Post reports. "The rare action by Congress reflects a growing body of scientific research showing that children ingest the toxins by acts as simple as chewing on a rubber duck. Used for decades in plastic production, the chemicals are now thought to act as hormones and cause reproductive problems, especially in boys."

The House-Senate agreement suggests the political shift toward consumer safety -- fueled by nearly two years of warnings about product dangers, including a host of imports from China -- hasn't lost momentum this election year. And it "also signals an important crack in the chemical industry's ability to fend off federal regulation," the Post says, noting that until yesterday the measure had bogged down in the House, where Exxon Mobil and other phthalate producers waged an expensive battle against the measure. Wal-Mart, Toys "R" Us and Target are among the retailers that had already begun to remove potentially dangerous products from their shelves and initiated their own testing regimes, The Wall Street Journal notes. President Bush has expressed support for overhauling the nation's consumer-protection system, but a White House spokesman tells the Post it is too early to say if the legislation could draw a veto.