Susan Heavey, Reuters, February 18, 2010

WASHINGTON, Feb 18 (Reuters) – U.S. Food and Drug Administration staff said they face difficulties in reviewing certain medical devices, hurdles that may call for additional regulations and authorities, even as the industry defended the current approval process.

At a public meeting Thursday, held to discuss possible changes to the FDA’s device program, agency staff said it is difficult to weigh new products under the accelerated review process used for products similar to those already approved.

It can be hard to tell if a new device is truly similar to an approved product or if there are enough differences to classify it as an entirely new product, they said. Difficulty inspecting devicemakers and a high number of proposed new products are also an issue.

“Developing clear definitions, guidance and additional authorities may be required,” said Heather Rosecrans, director of the FDA office that oversees such reviews, known as 510(k).

Devicemakers, industry consultants and investors said some smaller changes could improve the current process. They cautioned that a major overhaul could stifle innovation and prevent newer technologies from reaching patients and doctors.

FDA is weighing potential changes to the way it evaluates medical devices after a number of high-profile safety problems with heart defibrillators, contact lens solution and other products raised public concerns. Critics say the accelerated process is used too widely and can lead to problems after devices are sold.

Devicemakers are worried they could see longer review times, higher costs and other hurdles that may make it harder to get their products on the U.S. market. The threat of greater regulation affects smaller manufacturers as well as larger ones such as General Electric’s (GE.N) GE Healthcare and Siemens AG’s (SIEGn.DE) Siemens Healthcare.

Unlike traditional new drug and device applications, 510(k) reviews do not necessarily require clinical data on use of the device in patients. Just 8 percent to 10 percent of expedited device applications have patient data, FDA staff said.

Agency officials have said the meeting will help inform an internal task force charged with highlighting changes the agency can make with existing powers. An outside report from the Institute of Medicine, due next year, will focus more broadly on the FDA’s device division and what additional power or changes it needs.

Industry representatives were heavily represented at the meeting, something noted by the few practicing physicians and consumer advocates who also spoke.

Mark Leahey, president and CEO of the Medical Device Manufacturers Association, called the 510(k) process “one of the great successes” of the FDA, noting that “There are always areas for improvement.”

FDA staff said most devices are recalled because of manufacturing or design problems, something Medtronic Inc (MDT.N) Senior Vice President Susan Alpert said would not change even if the agency implemented changes to the approval process.

The FDA could issue more guidelines for companies to follow and focus more on staff training, other industry experts said.

Diana Zuckerman, the only consumer advocate to speak at the meeting, said newer, slightly different products are not necessarily better for consumers and can sometimes cause injury and death. She cited recent problems with Baxter’s (BAX.N) infusion pumps and massive recalls in 2007 of contact lens solution by Advanced Medical Optics, now part of Abbott Laboratories (ABT.N).

“In many cases these innovative devices are either not as safe as other products on the market, or not as effective,” said Zuckerman, president of the research and advocacy group National Research Center for Women & Families.

FDA officials have said they will accept public comments for the next month before making its task force’s recommendations public in June.[…]

Read the original article here.

Meg Kissinger, Journal Sentinel: January 15, 2010

The U.S. Food and Drug Administration on Friday reversed its much-criticized position on BPA safety, saying it was concerned about the chemical’s effects on fetuses, infants and children.

The agency said it would work to reduce exposure to the chemical, which is found in the urine of 93% of Americans tested. But it stopped short of a ban, saying more studies are needed to better know the chemical’s effects.

The agency also said it will move to expand its regulation of the chemical by trying to get manufacturers to report how much BPA they produce, where it is being made and how it is being used.

“We’d like a more nimble position to regulate this chemical,” said FDA Commissioner Margaret Hamburg.

The agency’s action, which was hailed by health and environmental groups, follows three years of investigative reports by the Journal Sentinel into the government’s failure to limit the chemical’s exposure, despite hundreds of studies that found BPA to cause harm.

In 2008, the FDA declared that BPA was safe for all uses based on two studies, both of which were paid for by the chemical industry.

The Journal Sentinel found that lobbyists for the chemical industry wrote entire sections of that decision.

The newspaper later obtained other e-mails that showed the FDA relied on chemical industry lobbyists to examine the chemical’s risks, track legislation to ban it and even monitor news coverage.

More than 6 billion pounds of the chemical are manufactured each year, accounting for nearly $7 billion in sales.

The chemical is used to line nearly all food and beverage cans. It is used to make hard clear plastic for baby bottles, tableware, eyeglasses, dental sealants, DVDs and hundreds of other household objects.

BPA, which leaches into food and drink when it is heated, has been linked to prostate and breast cancer, reproductive failure, obesity, heart disease, diabetes and behavioral problems.

BPA manufacturers, however, have maintained it is safe – and they did so again Friday. Lobbyists for the chemical-makers have regularly pointed to the FDA’s earlier ruling as proof for their stance.

The American Chemistry Council, the primary lobbying group for the  ac repair San Diego industry, characterized the FDA’s statement Friday as attempting to address “public confusion” on BPA, not valid safety concerns.

The group said it was “disappointed that some of the recommendations are likely to worry consumers and are not well-founded.”

The chemical has been banned for use in baby bottles in Canada, Minnesota, Connecticut, the city of Chicago and two counties in New York. Similar bills are being considered in Wisconsin, Pennsylvania and Washington. A federal ban for all food contact items has been proposed in Congress.

Some Seek More Action

U.S. Rep. Edward Markey (D-Mass.), who introduced a federal bill to ban BPA from all food contact items, praised the FDA’s move.

“It is clear that BPA poses serious health risks, and this finding is a major step toward eliminating exposure to this toxic substance,” he said.

Environmental and health groups also praised the announcement, though some said it did not go far enough.

The Environmental Working Group, which has been working to ban BPA from baby bottles and the lining of infant formula cans, said Friday’s announcement was a “Waterloo” for the chemical.

Others Were More Measured.

“This is a dramatic and overdue about-face for the FDA,” said Diana Zuckerman, president of the National Research Center for Women & Families. “They have finally admitted concern. They are moving cautiously, which is appropriate because you don’t want to substitute a new chemical that is equally dangerous. But it is essential that they not move too slowly.

“There is growing and disturbing research evidence that the health of children and adults is at stake.”

Recent studies showed 90% of U.S. newborns tested had BPA present in umbilical cord blood and that Chinese factory workers exposed to huge amounts of the chemical experienced sexual dysfunction.

Groups including the Breast Cancer Fund and the Consumers Union said they were disappointed the FDA did not take stricter action. […]

Read the original article here.

Denise Grady, New York Times: January 15, 2010

In a shift of position, the Food and Drug Administration is expressing concerns about possible health risks from bisphenol-A, or BPA, a widely used component of plastic bottles and food packaging that it declared safe in 2008.

The agency said Friday that it had “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children,” and would join other federal health agencies in studying the chemical in both animals and humans.

The action is another example of the drug agency under the Obama administration becoming far more aggressive in taking hard looks at what it sees as threats to public health. In recent months, the agency has stepped up its oversight of food safety and has promised to tighten approval standards for medical devices.

Concerns about BPA are based on studies that have found harmful effects in animals, and on the recognition that the chemical seeps into food and baby formula, and that nearly everyone is exposed to it, starting in the womb.

But health officials said there was no proof that BPA was dangerous to humans.

“If we thought it was unsafe, we would be taking strong regulatory action,” said Dr. Joshua Sharfstein, the principal deputy commissioner of the drug agency, at a news briefing.

Nonetheless, health officials suggested a number of things people could do to limit their exposure to BPA, like throwing away scratched or worn bottles or cups made with BPA (it can leak from the scratches), not putting very hot liquids into cups or bottles with BPA and checking the labels on containers to make sure they are microwave safe. The drug agency also recommended that mothers breastfeed their infants for at least 12 months; liquid formula contains traces of BPA.

BPA has been used since the 1960s to make hard plastic bottles, sippy cups for toddlers and the linings of food and beverage cans, including the cans used to hold infant formula and soda. Until recently, it was used in baby bottles, but major manufacturers are now making bottles without it. Plastic items containing BPA are generally marked with a 7 on the bottom for recycling purposes.

The chemical can leach into food, and a study of more than 2,000 people found that more than 90 percent of them had BPA in their urine. Traces have also been found in breast milk, the blood of pregnant women and umbilical cord blood.

Reports of potential health effects have made BPA notorious, especially among parents, and led to widespread shunning of products thought to contain the chemical. Canada, Chicago and Suffolk County, N.Y., have banned BPA from children’s products.

The government will spend $30 million on BPA research in humans and animals, to take place over 18 to 24 months, health officials said at a news briefing on Friday.

Dr. Linda Birnbaum, director of the National Institute of Environmental Health Sciences, said the research would involve potential effects on behavior, obesity, diabetes, reproductive disorders, cancer, asthma, heart disease and effects that could be carried from one generation to the next.

Activists on both sides of the passionately debated issue said they were disappointed in the government’s action. The American Chemical Council, which represents companies that make and use BPA, issued a statement saying BPA was safe, praising the health agencies as confirming that there was no proof of harm to people by it, but also saying, “We are disappointed that some of the recommendations are likely to worry consumers and are not well founded.”

Diana Zuckerman, president of the National Research Center for Women and Families, said the F.D.A. had not gone far enough, because its recommendations put the responsibility on families and not on companies making products containing BPA. In addition, Ms. Zuckerman said, the focus on safety should not be limited to children, because studies have linked the chemicals to heart and liver disease and other problems in adults.[…]

Gardiner Harris contributed reporting from Washington.

Read the original article here.

Allison Aubrey, National Public Radio: September 17, 2008

Read the original article here.

The Food and Drug Administration defended Tuesday a controversial compound found in plastic baby bottles and in food packaging. A major study has linked bisphenol A to possible risks of heart disease and diabetes.

Transcript:

STEVE INSKEEP, host:

The Food and Drug Administration has taken another step toward allowing continued use of a chemical. It’s a chemical found in everything from baby bottles, to food containers, to sunglasses, to compact discs. It’s called bisphenol A, or BPA. But a number of scientists say BPA is dangerous, and their side got a boost this week from a new study, as NPR’s Allison Aubrey reports.

ALLISON AUBREY: At a public meeting yesterday, the Food and Drug Administration made its case to a panel of scientific advisers. Michelle Twaroski, a staff toxicologist at the FDA, presented a PowerPoint on how her team assessed the risks of BPA using the best available animal studies, and she summed up the agency’s thinking.

Dr. MICHELLE TWAROSKI (Staff Toxicologist, Food and Drug Administration): In conclusion, FDA has considered the available data and determined that the margin of safety for bisphenol A exposure in all populations is adequate, and the continued use of bisphenol A in the manufacturer of food contact substance is concluded to be safe.

AUBREY: But during the next two hours of the hearing, the panel heard from members of the public and outside scientists who take issue with this conclusion. Diana Zuckerman heads an advocacy group called the National Research Center for Women and Families. She criticized the FDA for including so few studies in its assessment. She argued that relying on industry-funded animal studies is not a comprehensive approach.

Dr. DIANA ZUCKERMAN (President, National Research Center for Women and Families): Since these food containers are not proven safe, the FDA should not be assuring us that they are safe. It does feel like there’s been a rush to judgment by the FDA, and that does none of us any good.

AUBREY: One the studies not included in the FDA review is published this week in the Journal of the American Medical Association. It comes from researchers in Great Britain. They studied about 1,400 adults, the largest human study to date of BPA. And they found that people who had the highest levels of BPA in their urine were more than twice as likely to have developed diabetes and heart disease. This is compared to those who had the lowest levels of BPA in their urine. The study finds an association between these diseases and BPA, but it does not prove a cause and effect. Environmentalist John Peterson Myers wrote an editorial on the study that was also published in the medical journal. He spoke at the hearing yesterday.

Dr. JOHN PETERSON MYERS (Founder, CEO, Chief Scientist, Environmental Health Sciences): It is very clear that the FDA cannot conclude with certainty that BPA is safe. That option is no longer open to you given these new data.

AUBREY: Concerns about BPA have grown in recent years largely on the basis of animal studies. Some have shown that the chemical, even at low doses, can harm fetuses and offspring of mice and rats. Other studies, including some financed by the chemical and  action solar industries, find no cause for alarm. Steven Hentges heads the Polycarbonate/BPA Global Group of the American Chemistry Council. He says he trusts the FDA’s assessment.

Dr. STEVEN HENTGES (Executive Director, Polycarbonate/BPA Global Group, American Chemistry Council): We actually think the FDA draft report is quite comprehensive, it’s quite thorough. It included assessments from international bodies who have reviewed the scientific literature comprehensively.

AUBREY: The panel of FDA advisers now has six weeks to review the agency’s assessment and weigh in on whether they agree that the continued use of BPA in food containers is safe. Allison Aubrey, NPR News, Washington.

Diana Zuckerman, PhD, CNN Tonight: December 18, 2009

The following is the transcript from the segment.

LOUISE SCHIAVONE, CNN CORRESPONDENT (voice-over): A bipartisan effort in the Senate this week to open the nation’s doors to pharmaceutical imports seem to be on track with this campaign trail rallying cry from then candidate Barack Obama.

OBAMA: Then we’ll tell the pharmaceutical companies thanks, but no thanks for overpriced drugs.

(APPLAUSE)

OBAMA: Drugs that cost twice as much here as they do in Europe and Canada and Mexico. We’ll let Medicare negotiate for lower prices. We’ll allow the safe re-importation of low cost drugs from countries like Canada.

SCHIAVONE: A little more than a year after that campaign stop in Newport News, Virginia, the head of President Obama’s Food and Drug Administration urged a no vote on a drug imports bill proposed by North Dakota Senate Democrat Byron Dorgan. Commissioner Margaret Hamburg raising “significant safety concerns” and calling the measure “logistically challenging to implement and resource intensive.” Former Democratic congressional staffer David Sirota, now a left of center political analyst, says the Dorgan amendment would’ve achieved the goals of candidate Obama.

DAVID SIROTA, AUTHOR: Many of the drugs that people consume at their pharmacy right now are made not in this country. What this bill merely would have done would allow wholesalers and pharmacists to buy those drugs at the international world market price, a lower price than they’re being sold here. SCHIAVONE: The Dorgan proposal, with some Republican backing would’ve permitted licensed U.S. pharmacies and drug wholesalers to import FDA approved drugs from Canada, Europe, Australia, New Zealand, Switzerland and Japan, passing along the savings to consumers, savings which Dorgan says could have been in the tens of billions of dollars over the next 10 years. Those savings are no small matter to the National Research Center for Women and Families.

DIANA ZUCKERMAN, NATL. RESEARCH CENTER FOR WOMEN AND FAMILIES: We were hoping that the time had come when the American public and our public health would be the first priority, not the interests of drug companies. And that’s the biggest disappointment –that the drug companies — their lobbyists — as usual have had their say much more so than they deserve.

SCHIAVONE: The Center for Responsive Politics finds that from 1998 to the present, the pharmaceuticals and health products business was the top spending lobby, investing more than $1.7 billion. The industry leads the pack this year with expenditures so far listed at nearly $200 million. Pharma, the pharmaceutical lobby’s main voice offered no apologies telling CNN “the Dorgan amendment was defeated because common sense people recognize there is no way to guarantee the safety and efficacy of medicines brought into the United States outside of the FDA’s control.”

(END VIDEOTAPE)

Susan Heavey, Reuters: September 23, 2009

WASHINGTON (Reuters) – The U.S. Food and Drug Administration took its first steps to rein in the tobacco industry on Tuesday, implementing a ban on candy, clove and other flavored cigarettes.

The move, required by a law passed earlier this year giving the FDA greater power over tobacco products, aims to help prevent children and teenagers from smoking.

“Candy and fruit flavored cigarettes are a gateway for many children and young adults to become regular tobacco users,” Dr. Lawrence Deyton, head of the FDA’s Center for Tobacco Products, told reporters in a conference call.

In June, President Barack Obama signed legislation allowing the FDA to oversee the manufacturing and marketing of cigarettes and other tobacco products, including regulating ingredients and limiting advertising. The agency must also approve any new tobacco products.

Still, the bill excludes any immediate action on menthol, or mint, flavored cigarettes that are used by as many as 12 million Americans, including most African-American smokers. Lawmakers instead called on the FDA to study the issue.

It is not immediately clear how effective the ban will be or what impact it will have on smoking habits.

“Although it will take time for it to have a 100 percent effect … it will have a dramatic effect on children and young women who are most likely to smoke these products,” said Diana Zuckerman, president of the National Research Center for Women & Families.

Children who already smoke may switch to regular cigarettes, but many will be reluctant try smoking if products don’t taste good, she said. “I think it does make it harder for companies to try to get away with anything,” she added.

The ban in unlikely to affect U.S. tobacco companies such as Altria Group Inc’s Philip Morris unit and Lorillard Inc’s Lorillard Tobacco Co, which do not make flavored cigarettes.

But some advocates have already expressed concern that smaller companies will simply shift their attention to cigars, snuff and other tobacco products not covered by Tuesday’s ban.

The Campaign for Tobacco-Free Kids, which supported the FDA’s new oversight, said the nation’s top distributor of clove-flavored cigarettes, California-based Kretek International Inc., now sells clove cigars that look and taste like its clove cigarettes.

Representatives for Kretek, which imports most of its products, could not be immediately reached. Star Scientific and other companies also make dissolvable smokeless tobacco products in various flavors.

FDA’s Deyton said the agency would discuss other flavored products.

The FDA posted information about the ban on its website here

(Editing by Steve Orlofsky)

Marie McCullough, Philadelphia Inquirer: September 10, 2009

Government advisers yesterday recommended federal approval of Cervarix, the GlaxoSmithKline cervical cancer vaccine, after reviewing studies showing it is significantly more effective than Gardasil, the rival vaccine made by Merck & Co.

But Merck’s product, which has had a three-year head start in the U.S. market, got another boost yesterday when the committee urged the U.S. Food and Drug Administration to expand its approval for prevention of genital warts to a new market: males ages 9 to 26.

Both vaccines prevent infection with two types of human papillomavirus that cause about 80 percent of cervical cancers. Only Gardasil also protects against two types of HPV that cause 90 percent of genital warts.

While the FDA is not required to follow advisers’ recommendations, it usually does.

The latest endorsements will likely sharpen a rivalry with much local resonance. London-based GlaxoSmithKline P.L.C. directed much development of its vaccine at offices in the Philadelphia region, while Gardasil is made in and marketed from West Point, Montgomery County, home to Merck’s vaccine division.

The new studies also come as enthusiasm for HPV vaccination – hailed as a public health breakthrough three years ago – seems to be cooling amid persistent concerns about safety and questions about how long the vaccine protection will last. Gardasil’s sales slid 5 percent last year to $1.4 billion.

GlaxoSmithKline had submitted Cervarix clinical trial data and sought approval more than two years ago, but the FDA asked for more information. The agency was concerned that the vaccine’s novel “adjuvant” – a chemical that heightens immune response to the vaccine – might be triggering rare autoimmune diseases such as optic neuritis or Guillian-Barre syndrome.

In March 2009, GlaxoSmithKline submitted data from the single largest trial of a cervical cancer vaccine to date, with nearly 30,000 participants receiving Cervarix, some for as long as 6.4 years. The data showed that autoimmune diseases were not more common among vaccinated women than those in a control group.

GlaxoSmithKline also addressed another FDA concern – about spontaneous abortion. Although women were given a pregnancy test and told they should not be vaccinated if they were pregnant, about 7,200 got pregnant around the time of vaccination.

More spontaneous abortions occurred in the Cervarix group than the control group – 13 percent compared with about 9 percent – but this could have been by chance.

“I think we have to remember that both groups had lower spontaneous abortion rates than” normally occur in women in general, noted committee member Kenneth Noller, an obstetrician-gynecologist at Tufts University School of Medicine in Boston.

Like Gardasil, Cervarix is too new for scientists to know whether protection against HPV will last indefinitely. But Cervarix effectiveness data were clearly superior to those of Gardasil.

Like Gardasil, Cervarix was more than 90 percent effective at preventing precancerous lesions caused by the two “high-risk” HPV strains in women who had not been exposed to the virus before immunization. But Cervarix also was 75 percent effective at protecting against three cancer-causing HPV types that are not part of the vaccine, while Gardasil is only about 50 percent effective against one nonvaccine type.

In addition, blood tests showed that the concentration of virus-fighting antibodies was two to three times higher with Cervarix than with Gardasil – and remained high for 6.4 years.

By contrast, antibody levels fell back to natural pre-vaccination concentrations after two to three years in both males and females who had the Gardasil shots.

Merck officials say ongoing studies show that the vaccine remains effective in warding off warts and precancerous lesions despite the fall-off in antibodies. “But I would not tell you we’ll never need to give a booster shot” to Gardasil vaccines, Gregg Sylvester, Merck director of medical affairs for adult and adolescent vaccines, said in an interview after the hearing.

Others, like researcher Diana Zuckerman, say Gardasil is increasingly unappealing, especially considering that women have to continue to get regular Pap smears to screen for cervical cancer. Zuckerman is president of the National Research Center for Women and Families and a fellow at the University of Pennsylvania’s Center for Bioethics.

“Our center was excited when Gardasil was first approved, but the more we learned about how limited the data were, the more concerned we became,” she told the committee. “This is a very expensive vaccine – costing more than $400 – and we need to know how long it lasts. That’s true for women, and it’s even more true for men since the benefits are more limited. The boys of America are not facing an epidemic of genital warts.”[…]

Read the original article here.

Matthew Perrone, Associated Press: September 9, 2009

Printed in the Associated Press, The Houston Chronicle, San Francisco Examiner, and other newspapers across the country

WASHINGTON — Drugmaker Merck likely will face U.S. competition for its vaccine Gardasil, after federal experts recommended rival GlaxoSmithKline’s Cervarix also be approved to prevent the virus that causes most cervical cancers.

The FDA’s panel of vaccine experts voted overwhelmingly Wednesday that Cervarix appears safe and effective for girls and women ages 10 to 25. If the FDA follows the group’s advice as it usually does, Glaxo would begin competing against Merck’s Gardasil, which has controlled the U.S. market since 2006.

But Merck won its own small victory at the meeting, as the same panel recommended Gardasil be expanded to prevent genital warts in boys, a new use for a vaccine that already posts sales of more than $1 billion.

While panelists favored the expanded approval, they questioned how widely the vaccine would be used, since genital warts are not a serious medical condition.

“Genital warts are a nuisance, they’re ugly and can sometimes be stigmatizing,” said Dr. Kenneth Noller, of Tufts University. “But in men and women with healthy immune systems they go away by themselves.”

The human papilloma virus, or HPV, infects about 6 million people in the U.S. each year, and is mainly spread through sexual contact. It usually causes no symptoms and goes away within two years, though rare cases can develop into warts and cancer in both men and women.

Last year nearly 4,000 women died of cervical cancer in the U.S., less than 1 percent of all cancer related deaths.

London-based drugmaker Glaxo already has won approval for Cervarix in Europe, but its U.S. launch was delayed in 2007 when the FDA said it needed more data.

Panelists said newer studies suggest the vaccine is safe, but they recommended follow-up studies to monitor miscarriages and inflammatory-muscular problems reported by a small number of patients.

The group said it was unlikely those problems were related to the vaccine, but said the issues should still appear on product labeling.

“I think this could be marketed with the usual caveat that it’s not to be used during pregnancy,” Noller said.

Even if the FDA grants approval, Glaxo will face an uphill battle against competitor Merck. Besides an established brand in the U.S., Gardasil also boasts an extra degree of protection against sexually transmitted diseases.

Gardasil and Cervarix both defend against HPV strains 16 and 18, which cause about 70 percent of cervical cancer cases. But Merck’s vaccine also defends against two other HPV types that cause 90 per cent of genital warts, something Cervarix does not target.

Leerink Swan analyst Seamus Fernandez estimates Cervarix will eventually make up 25-30 percent of the total market for HPV-blocking vaccines. Cervarix global sales were $231 million last year.

In separate votes Wednesday, FDA’s panel ruled that Gardasil successfully prevents genital warts in boys and men ages 9 to 26.

While an approval decision from the FDA could theoretically double the market opportunity for Gardasil, analysts don’t expect much use among males.

“If it’s not preventing something serious like cervical cancer and there are questions about safety, I think a parents’ acceptance of the vaccine in young boys might be less urgent than for their girls,” Fernandez said in an interview last week.

Gardasil became an early success story for Merck after its launch, with sales growing to over $1.4 billion last year.

But momentum has slowed amid questions about the longevity of the vaccine’s effect and its cost effectiveness, considering its price tag of nearly $400.

Merck has tracked HPV immunity out to five years in women, and just three years in boys and men. Public health advocates argued Gardasil should not be approved for boys without evidence of its long-term effectiveness.

“The boys of America are not facing an epidemic of genital warts,” said Diana Zuckerman, of the National Research Center for Women and Families in Washington, during a public comment period. “We have time to wait for better data before approval.”

Dr. Richard Haupt, Whitehouse Station, N.J.-based Merck’s head researcher for Gardasil, said the company plans long term studies to track the vaccine’s effectiveness over time.

“Our long term evaluations will look at immune response, but more importantly they will look at disease prevention over time,” said Haupt.