DeLauro Discusses Drug Safety with Drug Industry

Press Release

DeLauro Discusses Drug Safety with Drug Industry

Washington , D.C. - Congresswoman Rosa L. DeLauro (Conn.-3) delivered the following remarks at the Institute for International Research/ Pharmaceutical Marketing ( Philadelphia , PA ). This address continues the series of policy speeches aimed at examining the Food and Drug Administration's commitment to protecting public health focusing on its ability to ensure the safety of our food supply and drugs and devices. Earlier this week DeLauro spoke at an event hosted by the Partnership for Food Safety Education. This series will continue over the next two weeks with speeches before the Consumer Federation of America (DC), the Food Law & Regulation Conference ( Chicago , IL ) and will culminate in a comprehensive address discussing the future of the FDA at George Washington University (DC) on October 3, 2007.

Below is the text of DeLauro's remarks [as prepared for delivery].

"This is a special opportunity for me to speak with a very impressive group of people, many of whom are the public face and public voice of your industry.

"I am here -- we are all here -- because we recognize the drug industry's tremendous impact. I value its powerful work and significant investment. I appreciate the strength and livelihood it provides our nation's economy, our scientific community, and medical professionals. And I will never underestimate the important role it plays in the lives, the everyday lives, of millions of Americans. By bringing life-saving drugs to the marketplace, we are applying our country's greatest resource -- its innovative spirit -- to help more people live longer, healthier, more productive lives.

"Most people at some point in their lives experience the direct reach and power of medicine to cure illness, heal wounds, or halt disease. It has become part of the human experience, and I am joining you here today, as someone who has felt that power deep down in her soul. More than 20 years ago, I was diagnosed with and battled ovarian cancer.

"We all know that cancer is an indiscriminate disease -- cancer does not care about your age, your family, your sex, your race, or your religion. It reminds us that we are human and vulnerable. But, as every survivor knows, it brings out your resilience, your strength, and it makes you value and really savor every moment of your life afterward. It also helps you appreciate modern medicine's power to save lives and make days like this day and every day, even more special.

"As a member of Congress, I have the special privilege of pursuing public policies that recognize and honor that remarkable possibility. I also have the challenge of finding the best policies, and striking the right balance to help bring medicine to as many people in need as possible. Fundamentally, my challenge as a policy maker is to ensure drugs are both as effective and as accessible as possible, both today and in the future.

"Those goals are pretty basic and pretty clear; but of course, the path to achieve them is not always. And for many years, many good people have disagreed when it comes to what the right public policy should be on drug safety and marketing.

"There is no doubt, I have a different perspective than the many representatives of the drug industry here today. And I am not here to pretend those differences do not exist. We must acknowledge our disagreements and understand how they affect your business and my work, your consumers and my constituents. But while we must recognize these differences -- I have not come here today to stubbornly shut you out, either.

"What I want most, is a conversation -- and what we get too rarely in Washington DC : an open exchange of ideas, that search for common ground. I am open to that discussion. I look forward to an ongoing exploration, together with you, about the most effective way to ensure patients get the best care, the best medicine, and the best information possible.

"I will be honest, I believed we were heading in that direction earlier this year when we began to consider the Prescription Drug User Fee Act (PDUFA).

"There was a lot to be proud of in the bill, adding new transparency and providing new resources to ensure the safety of the drugs and devices we count on everyday to fight disease and stay healthy. It expands the FDA's ability to monitor the safety of drugs and medical devices after they have been approved and marketed, increasing by $225 million over five years the user fees the agency can use for post-market safety monitoring and that is a good thing.

"The FDA would be required to revisit the drugs several years later for further analysis. And for riskier drugs, there would be regulation limiting prescribing authority to trained physicians. And by providing funds for the active analysis of large medical databases, this bill will also help us quickly detect drugs with major short- and long-term safety problems.

"However, there are significant improvements we could have made to the bill, but ultimately did not. It does not, for example, provide any mandatory recall authority for the FDA to immediately pull products off the shelves after they are found to be dangerous. We cannot forget that many high-profile drugs recently taken off the market had to be removed voluntarily -- and that was only after significant damage had already been done.

"What is more, this bill creates a new risk evaluation and mitigation strategy for new drugs that would create specific requirements and criteria for each drug. Under the original draft, drug or device companies would have been subjected to a $20 million maximum fine for a single violation and a $100 million maximum fine for several violations.

"These figures were reduced, however, to $250,000 and $1 million as the bill moved forward. As you know, this is mere pocket change for drug companies and provides little deterrent for companies that choose to ignore the new process.

"When it comes to addressing significant conflicts of interest at the FDA, the language in the final bill is actually weaker than what the FDA itself proposed earlier this year. The agency, in fact, would have prevented any members with conflicts of interest from voting on an advisory panel, and would have prevented any member with more than $5,000 worth of investments from even serving on the panel. The final bill however, allowed the FDA to grant waivers overriding its lenient current conflict of interest rules.

"And finally when it comes to direct-to-consumer advertising, the review system this legislation establishes is completely voluntary, while giving the FDA no authority to require changes.

"Of course, it is possible to look at any number of provisions within PDUFA - and find strengths and weaknesses. That is the essence of compromise, the nature of any large piece of legislation, and the reason I voted for the final version of the bill, which the House passed this Wednesday.

"That is also why I will work from my seat as the Chair of the Agriculture/FDA Appropriations Subcommittee to improve those provisions in future spending bills. And why, with this year's Agriculture Appropriations bill we appropriated $6.25 million in funds for the review of Direct to Consumer advertising, instead of relying on the voluntary program outlined in PDUFA - a voluntary program might as well not exist at all. It is that provision from this week's PDUFA legislation, which in many troubling ways, illuminates the greater challenges facing drug safety and marketing in America today.

"Just one year ago, for example, September 2006, television stations began running an advertisement for a sleeping aid. The voicever announced, quote: "Rozerem would like to remind you that it is back to school season. Ask your doctor today if Rozerem is right for you." The words played over images of chalk boards, school books, a school bus, laptops, and school-aged children with backpacks.

"What most viewers did not know at the time was that the drug included a precaution for pediatric use, its safety and effectiveness for pediatric patients had not been established and it has been associated with an effect on reproductive hormones. But that did not stop the drug makers from running an ad targeted at children.

"It is no surprise that the FDA followed with a letter encouraging the makers of the drug to pull the advertisement. What is surprising however, is that the letter came in March 2007, a full 6 months after that back-to-school season.

"I promise, I am not here to slap anyone on the wrist or even to continue with a long list of particularly egregious instances of Direct-to-Consumer advertising gone wild. I know we can all agree, a few embarrassing examples do not represent the majority of ads that mean to do no harm.

"But the reason this case is worth considering today, is its power to shed light on some far greater failings in our current system. It is not just the impatient rush to get the latest product into the hands of the most consumers. And it is not just an FDA that is slow to react, and unable to compel action. It is what happens when these conditions collide. It is what happens when there is no one to weigh the consequences, no one to address the neglect, and no one to sustain our most vulnerable populations.

"Together -- not just the drug companies, not just the government, patients or doctors - but all of us together, we have a responsibility to seriously reexamine the way we package, share and evaluate information about drugs. The system in place today is simply not good enough.

"The provisions laid out in PDUFA, start by creating a program giving the FDA the authority to collect fees for voluntary agency review of prescription drug direct-to-consumer television advertisements. Companies would be charged a fee for initial participation and a fee for each review request.

"But we all know what the key word is there: voluntary. And that is its greatest shortcoming. The direct-to-consumer advertising gives the FDA zero authority to require changes. If a drug company chooses to volunteer for the review system and pays a fee, it can run its advertisements regardless.

"The FDA has important oversight responsibilities; and the push to promote new drugs should not get in the way. Public relations should never trump public health.

"I agree, advertisements can play a role, educating the public about potential health problems, providing valuable information, and bringing patients into their doctor's office to begin an important conversation.

"There are benefits to be sure, but the truth is that beyond mentioning the name of the drug and the problem it treats, most direct-to-consumer ads have minimal educational content. So we must weigh that content and its benefits, against the potential dangers of leaving consumers vulnerable to unexplored post-approval risks and misleading claims.

"And that is no small risk -- especially if we continue failing to give the FDA the teeth it needs to enforce its own standards. Consumer advocates continue to find a broad and frightening array of confusing messages that minimize products' risk, exaggerate their efficacy, make false claims of superiority over competing products, promote unapproved uses, and even promote drugs still in the experimental stage.

"We are seeing similarly vague ads on TV and in magazines for medical devices such as hip and knee replacements, giving either no indication of the potential complications and side effects from the major surgery they require.

"When hospital acquired infection kills about 100,000 people a year, with a cost to society of about $27 billion, it is time to reexamine the way our society discusses major surgery and encourages people to pursue it. It is time for the FDA to take a close look at these ads and their alarming failure to paint the whole and honest picture.

"I must admit that in the weeks ahead, I am scheduled to undergo a hip replacement myself. For most people, this kind of surgery promises a great release from a lot of pain -- and I hope that will certainly be the case for me. The diagnosis, however, came from my doctor, not Ladies Home Journal -- and after getting all the details, positive and negative, from my doctor, I thought long and hard about all the risks and consequences of the surgery -- discussing them with my family.

"Of course, every business has the right to promote its products. And I will never fault anyone for working to protect that right, or boost its sales -- that is how the marketplace works. But, the marketplace works best when everyone is free to make their decisions with the most complete and credible information.

"Unfortunately, direct-to-consumer advertising in its current form, too often hides all the facts, making it harder, not easier, for patients to make the best decision about their health. A handful of bad actors (and I am not talking about the beautiful people performing in those commercials!) -- they undermine our faith in the entire industry and our confidence in the system meant to protect us.

"Both the government AND the industry have a compelling interest in making sure consumers get the full and straight story. When consumers are trusted to make informed decisions over the long run, unclouded by the anxious, race to pump up the latest drug just on the market, their confidence in that market will only grow. So too will their trust in the information they receive and the people providing it.

"Therefore -- while questions of a drug's safety are still being examined and considered -- a moratorium to ban advertisements for a period after approval is essential. During the last Congress, I introduced The Responsibility in Drug Advertising Act to do just that, making sure consumers know what they are getting, and for drug makers to know what they are promising. This would be a vital improvement over PDUFA's voluntary system.

"Ultimately, when we talk about transforming direct-to-consumer advertising, we have the opportunity to look at it as part of something bigger -- examining it from the perspective of all those children, families, and seniors that any serious drug safety and marketing reform will inevitably touch.

"This is about our federal government finally recognizing an obligation to its citizens. For too long the mechanisms in place to protect the public health have been ignored and neglected. In Congress, and across America we have to assume that responsibility again and get it right.

"This is something we can work on together. For decades, the drug companies have been recognized for their ground-breaking research and innovative science -- now let us take on an innovative collaboration.

"Let us sit down together and find the new policies that serve our common purpose and clear the path for a successful industry and accessible, effective drugs. We can differ on some important issues, yet share the same faith in the great promise of a healthier, more productive America .

"So please, consider this an official solicitation - give me your ideas, share your thoughts with me and my colleagues in Congress. Let us start talking - private sector and public sector, both parties.

"I support your work to expand research for drugs to treat rare diseases. I know they are not always as lucrative, but we all know critical innovation and investment in this area must be. About 25 million Americans suffer from more than 6,000 such rare and puzzling diseases, each of which affects fewer than 200,000 people. As a member of the subcommittee that funds National Institutes of Health, I want to work with you in this area to make the proper investments and help Americans that suffer from rare diseases.

"And I also look forward to collaborating with the industry in its ongoing work to address our nation's growing diabetes epidemic - increasing awareness, promoting nutrition, giving children and families the tools and choices to avoid diabetes, obesity, and other dangerous health conditions.

"If we are all flexible and open, I believe there is a lot of common ground we can find. Together, providing for an easy, effective system in which transparent educational content about drugs reaches more consumers. Together, building a genuine post-market surveillance system to review the safety of drugs after approval to ensure they remain safe for everyone. Together, establishing an effective review system rooted in respected advisory committees with minimal conflicts of interest.

"By meeting openly and working seriously in partnership, we can honestly understand one another's positions. And I believe we can open the door for new drugs and address obstacles that stand in their way. We can earnestly create a place where safety and growth are not mutually exclusive, finding policies that work for both the industry and the consumer.

"When we do, the rewards will be great."

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