One thing that has come out of the widespread egg salmonella outbreak of the last two weeks is a resurgent call for the FDA to be given better tools to protect the public from unsafe food and drugs. Batches of eggs contaminated with salmonella have sickened hundreds of Americans, leading two Iowa egg producers to recall more than a half-billion eggs from store shelves. This week, FDA Commissioner Margaret Hamburg asked Congress once again to give her agency the authority to recall unsafe or contaminated foods. The agency has asked for similar authority for drugs in the past.

Congress is close, sort of. In July 2009, the House passed a comprehensive food safety bill giving the agency recall authority and better inspection resources. Though a Senate committee passed similar legislation, it never reached the floor. The egg crisis could and should change that.

The FDA should also be able to recall drugs that have been adulterated or found unsafe, rather than relying on a company to issue a recall, as it must do now.  The Drug Safety and Accountability Act of 2010, introduced earlier this summer by Sen. Michael Bennet, would give the agency that authority. In July, Rep. Edolphus Towns introduced a bill to give the FDA recall authority for drugs, spurred on by his committee’s investigation into the J&J recalls earlier this year.  And Rep. John Dingell has said recall authority is a critical element of any FDA reforms. The ability to protect Americans by coordinating recalls of unsafe food and drugs is an important tool the FDA should already have. Congress should grant it to them now, and not wait for another food or drug safety crisis to hit the headlines.

–Kate Petersen, PostScript blogger

As a report this week in the New York Times illustrated, patient harm caused by misconnection of tubes–such as feeding tubes inserted into veins—has been a recognized source of medical error for decades.

In April 2006, the Joint Commission issued a Sentinel Event Alert indicating that misconnection errors were an important and under-reported problem in health care organizations. Sentinel events are errors that are required to be reported to the Joint Commission Sentinel Event Database. That year, only nine cases had been reported–eight deaths and one permanent loss of function. Yet USP (United States Pharmacopeia) databases listed over 300 cases for the same time period.

The fact is that any number of cases over zero is unacceptable when such errors are entirely avoidable. Unfortunately, in health care, the way safety is approached is nineteenth century: Tell people to work harder to avoid making the mistake. No other industry would tolerate this antiquated approach for a second.

In 1961, Shigeo Shingo was an industrial engineer at Toyota Motor Corp; he came up with the concept of Poka-Yoke. If you want to prevent an error, design the product or system to be error or mistake-proof. Poka-Yoke is a process that:
•    Makes wrong actions more difficult
•    Makes it possible to reverse actions — to “undo” them — or make it harder to do what cannot be reversed
•    
Makes it easier to discover the errors that occur
•    Makes incorrect actions correct

That process is why you cannot take the keys out of your ignition if the car is not in park and why the dryer goes off when you open the door. Robin Rogers, a woman in the Times story who died with her unborn child after a feeding tube was inserted into her vein, did not die because the nurse connected the wrong tube or because the FDA was lax. Roger’s unnecessary death was because we have not insisted on the same industry standards that we demand for our air or car travel.

U.S. health care is a complex industry of multiple “free-enterprise” zones, many of which have little or no accountability. We have multiple regulatory agencies: the Joint Commission to oversee facilities, the Medical and Nursing Boards to make certain doctors and nurses are meeting standards of care, the FDA to regulate devices and pharmaceuticals. But each has limited authority and none guides the combination of events that result in a nurse in an understaffed hospital at the end of a double 10-hour shift connecting a tube that is carrying food for the stomach that has the same connection as the line to the intravenous route.

Car manufacturers have put in ABS into their car brake systems (another “fail-safe” system that prevents you skidding if you stomp on the brakes) because it has given them a competitive advantage. The competitive advantage occurs because the public understands car safety. There was a Congressional hearing when stuck accelerators caused a highway patrolman to crash, killing him and his family. Where are the Congressional hearings for the deaths of people who are even more vulnerable, having put their trust in the system that cares for their health?

FDA oversight ultimately depends on statutory authority as well as public will. We should pursue legislative solutions that require tubing manufacturers to make tubing used for different purposes (intravenous, oxygen delivery, drainage tubes, feeding) totally incompatible with one another, including inability to connect them to standard Luer locks. But the likelihood of accomplishing meaningful change given the current adversarial political climate is slim.

The other approach is a change in how we look at medical liability. Currently, we tend to hold accountable the last person to touch a system error: in these cases, the person who connected the two tubes. This is despite the fact that we know that if error can occur, it will occur.

It is time to demand that the accountability fall to the manufacturers of medical tubing – just as it falls to the manufacturers of planes and automobiles. We are past the “buyer beware” phase of medical devices. Isn’t it time we demand that the designers of medical tubing produce products that are not just safe, but error-proof?

–Lynn Parry, M.D.
Chair, Colorado Prescription Project

Last week the Association of American Medical Colleges and three other university associations took aim at the NIH’s proposed rule to tighten disclosure and reporting requirements, departing from their initial support of tightened regs last summer.

Like the AAMC and Association of American Universities (AAU), who joined AAMC in its comments, we voiced our support for reform and suggested ways to strengthen reporting and transparency when the NIH solicited public comment last summer on ways to shore up rules aimed at promoting objectivity in research.

This May, the Institutes issued a proposed rule with many strong reforms (you can read about that here on PostScript.) The rule was amended and the comment period extended after it came to light that an National Institutes for Mental Health director Thomas Insel had recommended psychiatrist Charles Nemeroff for a job at University of Miami, despite Nemeroff’s failure to report large sums he received from GlaxoSmithKline while working on an NIH–backed grant on a GSK drug. That violated NIH rules and led to his resignation from Emory University, but Insel apparently assured Miami administrators that Nemeroff would be eligible for NIH funds at a different university. (Carlat Psychiatry Blog and Pharmalot have the backstory.)

In its newest comments, AAMC asks for reporting exclusions that would significantly weaken the proposal.  As currently written, NIH would exempt disclosures only for seminars at institutes of higher ed and government agencies. AAMC suggests exempting all speaking gigs, lectures and seminars at academic teaching hospitals, medical centers, research institutes affiliated with an institute of higher education, and other non-profits involved in research.

They also suggest that travel funds be exempted from reporting requirements, as well as any funding for CME presentations that meet ACCME standards. However, in this compliance-savvy climate, most industry-backed CME presentations in which NIH investigators participate are ACCME accredited – and such accreditation does not eliminate inherent bias in such programs.

Unfortunately, those are pretty big slices of the pie. A lot of research-related dollars are flowing through third parties at this point—including the non-profits and other third parties that AAMC asks to be exempted. Most patient organizations and professional medical associations are non-profits, and the grants money they receive is often passed on to individuals for fellowships, participation in research symposia, or education. As you can see on Pfizer and Lilly’s websites, most grant recipients from the two drug companies listed here are non-profits, and many of those grants seem to be for these research-related purposes.  
Just because they are issued through a non-profit does not mean these funds cannot somehow influence how an investigator conducts his research.

The AAMC and its cosigners also suggest that NIH should rely first on investigators to decide what to report, based on their judgment of the relatedness of a financial interest to their research.

Well, this is how much of this started – Sen. Grassley and others found that investigators, who decide under current regs what they do and don’t report to their institution, weren’t reporting some pretty big industry payments related to their research. See Nemeroff, Schatzberg, Biederman, et al. In most cases, the medical schools that AAMC represents were the ones to get the bad press and in hot water for these omissions. The NIH proposed rule change would help protect these institutions by taking the evaluative reporting decision away from the investigator. With the Sunshine Act providing a national database of company payments to physicians and teaching hospitals, we don’t want institutions that are accountable to NIH to be caught out if they aren’t aware of a payment to an investigator that shows up in the Sunshine database.

The AAMC also proposes that if undisclosed conduct is discovered, an investigation could be waived.  But we support NIH’s proposed mandatory investigation if someone fails to report a Financial Conflict of Interest (FCOI). The new regs were proposed and will be implemented for good reason. There is no current mechanism for NIH or an institution to judge whether an investigator failed to report a FCOI “in bad faith” or whether the unreported interest affected research. Unless you investigate, there is almost no way to uncover intentional and problematic non-disclosures. We can’t count on whistleblowers to enforce this.

Worryingly, the groups frame their comments by calling into question the very need for the reforms.

There is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity. In the absence of such evidence, onerous regulations are not only unwarranted, but could create a glut of policies that increase activity without adding protections and at the same time erode the trust between the regulators and those being regulated.

We think this is a tough claim to make, since the rule was proposed and amended in large part because of Congressional investigations and media stories that revealed millions of dollars of undisclosed industry funds in the hands of publicly-funded researchers.

While there may be no study yet that links disclosure of FCOIs to research integrity, there is increasing evidence of bias in research and disclosure is one step we can take to try to reduce this bias.

–Kate Petersen and Ian Reynolds, PostScript

A significant vote by the Senate Appropriations Committee last week has focused renewed attention on vital cost-saving reforms on prescription drugs that failed to make it into health reform. At issue is the drug industry practice of paying off generic competitors of expensive brand-name drugs to delay access to low-cost generics. Community Catalyst has opposed this practice through our advocacy and with consumer class action lawsuits through our Prescription Access Litigation project.

How serious are these multi-million dollar sweetheart deals that prevent consumer and health system savings? The Federal Trade Commission, the federal government’s consumer protection watchdog, reported in January that these agreements delay the entry of generic drugs into the market by an average of 17 months. Given that generic entry can reduce the price of branded drugs by up to 90 percent, the FTC estimates conservatively that the cost of these delays is at least $3.5 billion in lost savings per year.

Through these pay for delay deals, the brand-named drug manufacturer gets to continue to be the exclusive seller of the drug and the generic manufacturer makes money for not bringing a generic (non-patented) version of the drug to market. It is then left to consumers and the government to pay the price for the high drug costs that result from these agreements.

21 new pay-for-delay deals in 2010 may cost consumers and the health care system $9 billion

The FTC warned in recent Congressional testimony that pay-for-delay agreements are becoming more common and have reached the point of being “almost an epidemic” (see graph). Deals rose from only three in 2005 to 19 last year and 21 in the first nine months of 2010. This dramatic increase followed court decisions since 2005 by a few appellate courts that, according to FTC, “misapplied the antitrust law” to uphold these agreements as not anticompetitive.

The FTC’s preliminary analysis of the 21 agreements filed this fiscal year concludes that they cost $9 billion in lost savings. Past pay-for-delay agreements to date are estimated by FTC to cost all public and private purchasers at least $20 billion — an estimate that may rise given the current spike in agreements. FTC estimates that these settlements cost consumers and our health system at least $3.5 billion a year, while other experts suggest that the potential total savings could be closer to $12 billion a year if pay-for-delay settlements were ended.

The federal government — and health reform sustainability — would benefit greatly from banning these agreements. The Congressional Budget Office estimated the savings to the federal government alone of around $2.6 billion over the next ten years.

Legislative History

A bill to ban these agreements was included in the House’s health care reform proposal last fall. Unfortunately, though a similar measure was supported by the White House and considered by the Senate, the procedural and jurisdictional rules in the Senate kept the measure from being included in the national health reform bill enacted last March.

House leaders were undeterred by this set-back and added language banning these deals to an appropriations bill approved on July 1st. Unfortunately, the Senate went on to strike this provision from an appropriations bill they subsequently approved. But two weeks ago, the bill’s longtime advocate, Senator Herb Kohl (D-WI), along with Senator Richard Durbin, succeeded in including this provision as an amendment to the Senate’s Financial Services and General Government Appropriations Act.

On July 29th, an effort by pharma to strip this provision was narrowly defeated in the Senate Appropriations Committee. Senator Arlen Specter (D-PA) had introduced an amendment to strip the provision from the Committee bill, and when four other Democrats voted with Specter, the Associated Press reported that:

“Drug company lobbyists in the audience thought they had the vote won, provided they could win over every panel Republican. But Sen. Richard Shelby, R-Ala., voted against the drug companies, helping give Kohl and Durbin [the author of the Appropriations Bill] a surprise win.”

The successful Senate Committee vote signaled to FTC Chairman Leibowitz that “the tide may be turning,” and that “consumers are one step closer to saving billions on their prescription drugs.”   The bill’s Senate sponsor, Senator Kohl, pointed out why this decision can’t come soon enough:

“The cost of brand-named drugs rose nearly 10 percent last year. In contrast, the cost of generic drugs fell by nearly 10 percent. At this time of spiraling health care costs, we cannot turn a blind eye to these anticompetitive backroom deals that deny consumers access to affordable generic drugs.”

This recent vote is a crucial step. The potential savings to both consumers and the government is substantial and is particularly important in these turbulent financial times. A New York Times editorial this week emphasized that these potential savings “would reduce the federal deficit by $2.6 billion over the next decade, freeing up money for worthy programs that would otherwise be cut.”

Why should we allow these agreements to continue to the financial benefit of only a small subset of the U.S. population when the savings that would result from banning these agreements could benefit a far greater number of individuals? It is about time for the pay-for-delay settlement to meet its long-awaited demise.

The final vote in Congress on the Appropriations bill will likely come sometime after the election. It will take vigilance and aggressive action by supporters to combat PhRMA’s tactics again — just last week they released a new report disputing the FTC analysis. But in Pharmalot, an FTC representative states: “The pharmaceutical industry can fund as many studies as it wants, but it can’t change the facts — these pay-for-delay deals cost consumers $3.5 billion a year.”

– Emily Cutrell, legal intern
– Wells Wilkinson, Director of Prescription Access Litigation project

In the spirit of covering spirited drug safety hearings, we feel we ought to point out (if a little belatedly) Rep. Steve Buyer’s animated exchange on counterfeit drugs during an Energy and Commerce Health Subcommittee hearing on antibiotic resistance in farm animals in July.

Buyer (R-IN) has established for himself a reputation as a watchdog on counterfeit drug issues. In 2008, he joined with Rep. Jim Matheson (D-UT) to introduce the Safeguarding America’s Pharmaceutical Act, which would require the federal government to establish a track and trace system so that drugs would have a traceable pedigree from the manufacturer to their arrival on pharmacy shelves. The bill would also establish protocol for counterfeit drugs identified by FDA at the U.S. border.

Though Rep. Buyer has announced he’s retiring at the end of this term, he made clear during the antibiotics hearing that he intends to introduce more counterfeit legislation alongside colleague and drug safety advocate John Dingell.

Below are highlights from this portion of the hearing. The full preliminary transcript can be found here.

Mr. {Pallone.} Next is the gentleman from Indiana, who has 8 minutes. Mr. Buyer.

Mr. {Buyer.} Thank you very much. Dr. Clifford, I have a question that deals with adulterated, counterfeit, knockoff drugs. We have a problem in our country, and countries around the world are challenged by this. Do you see any escalation or any evidence of adulterated counterfeit drugs in animal health?

Dr. {Clifford.} Congressman, since this really falls under FDA’s jurisdiction, I would have to turn to them to answer that question.
…

Dr. {Sharfstein.} For animal health, I think we are going to have to get back to you. I am not prepared to answer that. I have not heard of a significant counterfeit problem in the United States but I want to make sure and get back to you.

Mr. {Buyer.} You know, as our problem is growing, it is only time before it migrates. It is going to follow the money, right? Bad guys follow the money. And that is why I asked the question.

I want to thank the FDA for continuing the blitzes that you are doing at international mail facilities, so thank you for doing that. You are trying to “get the word out” to Americans that if you go on the Internet and you think that that is an approved website to order your pharmaceutical products, that you are really playing Russian roulette with your life, and so thank you for keeping these blitzes going and trying to get the word out. I noted in your testimony when you were with us in March, you had in your testimony, “Protecting Americans from unsafe or contaminated drugs is not just an important responsibility of the FDA, it is our core charge.” Do you agree with that today?

Dr. {Sharfstein.} I do believe that. I think it is one of the reasons that FDA—

Mr. {Buyer.} So–

Dr. {Sharfstein.} –was established.

…

Mr. {Buyer.} You also then in your testimony talked about FDA must adopt a new approach. Now, I think when you talked about your new approach, also you were concerned about the production, i.e., raw ingredients, that are used within our supply chain for which people are buying at retail outlets within the gold standard of our own country. So ensuring that we maintain that gold standard, you are putting your eyes on that supply chain and production. I don’t have any problems with that. I think that is wonderful. I think the Administration is doing what it is supposed to do. I applaud you with regard to your striking the agreements with other countries, putting more inspections on other soils. That is awesome.

…Now, as we are doing this, we have got both of these going on at the same time, is we are trying to then do our electronic pedigree, and Mr. Dingell has a bill, and we are going to do work and do this electronic pedigree, but let me tell you what I was bothered about what I read in the Miami Dade about your last blitz. I think it is great. Like I said, you are doing the blitz. You did a 3-day blitz. You did everything you were supposed to do, your coordination with Customs, Border Protection, thousands of pieces of foreign mail. You X-rayed them. You separated them. You identified them, the suspicious pharmaceutical products. You ID’d them. You showed how many of them were counterfeit and knocked off, and then you sent them back.

America has to be shocked, and the counterfeiters have to be excited that America is a place where you can counterfeit your drugs, send them to America, steal people’s money, and the American government will send the counterfeit drugs back to you so you can then send them to someone else that you can steal more money from. This is like one of the dumbest policies I think we have in this country…

I know you have got to be uncomfortable with that as a policy. Are you?

Dr. {Sharfstein.} Yes. I mean, I have spoken to some of the inspectors who are, you know, as frustrated as you are.

Mr. {Buyer.} All right. Now, if you are willing to step into a new–and that was your testimony that you gave to us in March, that you embrace and wanted to adopt a new approach with regard to the raw ingredients, through production and distribution always to U.S. consumers, I think I have an opportunity. I think, Mr. Dingell, we have an opportunity to help protect America, and that is embrace what the FDA is saying here, Mr. Dingell, and let us figure out how we can destroy these when they are identified, when your inspectors identify them. Let us not send them back to the counterfeiters so they can continue to rip off people. You know, Doc, come on, they are preying upon the most vulnerable of our population, which is awful. Would you be willing to work with Mr. Dingell and I to come up with a policy here that can give your inspectors the ability to destroy these counterfeit, knockoff, adulterated drugs?

Dr. {Sharfstein.} Yes, and I believe we have been already starting that process by working with your staff and Congressman Dingell’s staff on this issue.

Mr. {Buyer.} All right. Well, I want to be as proactive as we possibly can. John Dingell, to his credit, started this a long time ago with his paper pedigree, and he has always had a great interest. It goes all the way back many years into the 1970s, and I applaud what he has done. I think he has got to be pretty shocked on where America is today compared to where we were in the 1970s, and as a policy and I know you adopted this, I was just as frustrated with the last Administration but I am embracing your spirit, and if we are able to move ahead, Mr. Dingell, I want to join with you today and I want to work with the FDA and I want to resolve this matter. I want to yield to the chairman for a second.

Mr. {Dingell.} I thank the gentleman. He is most kind to me, and I want to thank him for the kind comments he has made about me. I want to assure him that my assurances of the last Congress, I would be happy to work with him, and I happen to agree with the gentleman about the problem of imports, about tracing pharmaceuticals and other drugs, and I am pleased to report to the gentleman that very shortly we will be circulating a draft for comments about pharmaceutical safety, and I hope that the gentleman when that occurrence happens that he will look at it with sympathy and I look forward to working with him because he is a valuable member of the committee, and I thank him.

Mr. {Buyer.} I thank the gentleman. The last, can I do this piece of math? Thirteen-

-

Mr. {Pallone.} The gentleman’s time has expired, but all the love–

Mr. {Buyer.} I ask unanimous consent for 30 seconds.

Mr. {Pallone.} Yes, with all the love and bipartisan here–

Mr. {Buyer.} God bless you.

Mr. {Pallone.} I certainly don’t want to stop the gentleman.

Mr. {Buyer.} Thirteen international mail facilities, on average 35,000 are pharmaceutical packages, times 365 days, that is 1,666,075 packages a year. If 80 percent are counterfeit, adulterated or knocked off, that means there are 132,860 pharmaceutical packages that are coming into the country that are either adulterated, counterfeit or knockoff, and people are taking these and they are not metabolizing in the body in ways in which as doctors you intend. With that, I yield back.

–Kate Petersen, PostScript blogger

Earlier this month, the U.S. Court of Appeals in Boston (First Circuit) upheld Maine’s 2007 data-mining law, which bans the commercial use or sale of data showing what health practitioners prescribe to their patients. Over on Health Policy Hub, Ian Reynolds blogged about what the decision means in the context of earlier court cases:

The Maine law is nearly identical to laws in New Hampshire and Vermont that have also survived challenges by industry…

For those keeping score, we now have three variations of data mining laws in three states. We’ve got the total ban, the “opt-in” and the “opt-out.” Each of the states has also been given the go-ahead to implement its law, though we’re still waiting for the outcome of the final appeal on the Vermont statute.

The First Circuit ruling is another win for prescription privacy and public health advocates. But the ruling may be most significant because there isn’t really anything remarkable about it. It feels like we’ve been here before, heard many of the same arguments and had similar results. Even though these three laws differ slightly in how they go about it, they all have the same intent: to limit drug reps’ access to prescriber-identifiable data. The legal and public health arguments for limiting data mining are clear, and that’s been shown time and again. Last week’s ruling in Maine cited many of the same findings from Vermont and New Hampshire decisions: the statute is constitutional, does not infringe on free speech guarantees, stands to protect public health and will save public dollars.

Maybe this was strike three. Or maybe the final appeals court ruling on Vermont’s law will be strike three. Sooner or later it will come and advocates can focus on developing programs and systems that use prescription information to improve patient care, rather than simply defending against its use for marketing practices that drive up costs. With the passage of the new health law, we need smart strategies like these to make the health care system more sustainable while improving quality.

Read the full post here.

-Kate Petersen, PostScript blogger

Yesterday, Senator Michael Bennet (D-CO) unveiled new legislation that seeks to improve the safety of America’s drug supply. The Drug Safety and Accountability Act of 2010 is an important first step in solving a growing problem. It mandates improvement of industry safety and quality standards for both prescription and over-the-counter drugs, provides increased FDA oversight, and gives the FDA much-needed authority to actively protect the drug supply through mandatory recall of dangerous products, as well as to subpoena documents and witnesses. The bill also improves enforcement through whistleblower protections and civil monetary penalties for industry violations.

In announcing the filing of the bill, Sen. Bennet shared his concerns about the issue and his commitment to ensuring the American drug supply is safe no matter where its drugs are made. “Making sure pharmaceutical drugs meet the highest standards for safety and quality is important to me, not only as a U.S. Senator, but as the father of three little girls as well,” said Sen. Bennet in a press conference organized by the Pew Prescription Project. “For too long, the FDA has lacked the proper authority to adequately safeguard our drug supply and protect Colorado consumers.”

Why now?

Americans are concerned about the drug supply, says a Pew Prescription Project survey released yesterday, and they have reason to be.

Manufacturing of pharmaceuticals has changed dramatically in recent years, with more than 80 percent of the active ingredients in all U.S. prescription drugs now originating overseas, often in countries with weak regulatory and enforcement infrastructures such as China and India. In these counties, where quality standards differ from our own and where responsibility for drug purity is murky at best, it is increasingly difficult for the FDA to ensure the safety and efficacy of a drug when they cannot track the uncertain and complex manufacturing processes.

According to the Pew Prescription Project survey, the confidence Americans have in drugs made in some countries overseas is next to none. While three out of four Americans believe drugs made in the U.S. are contaminate-free, only one in 10 believes the same for drugs made in China or India. What’s more, most believe Congress should do more to legislate in this area and over half of those surveyed favor FDA inspection of overseas drug companies.

The recent recalls of Johnson & Johnson’s children’s Tylenol and other cough & cold medicines were another wake-up call to protect Americans from the risks of unsafe drugs, but they were also the most recent in a long line of issues.

The numbers are telling

• In June, drug manufacturers recalled intravenous bags of certain antibiotics manufactured in India found to be unsterile and at least in one case to contain mold.
• In May, the FDA sent a warning letter to a pharmaceutical company for failing to set quality standards for its outsourcing that allowed them to skirt important safety practices.
• There were more than 1,700 drug recalls in 2009 – four times more than in 2008. Most of the recalls were for problems related to manufacturing quality and testing.
• In 2007 and 2008 a contaminated blood thinner, heparin, made in China entered this country and more than 100 Americans died in that case.

Community Catalyst is collaborating with the Pew Prescription Project to spearhead work on this issue in the best interest of American consumers.  The impact of drug safety problems is potentially enormous, given that adults and children alike have increasingly come to rely on pharmaceuticals for the cure and management of a wide variety of common, chronic and serious medical conditions. Indeed, Kaiser reports that the use of prescription medications has risen 39 percent in the last decade in the U.S. while the population grew 9 percent. Today 90 percent of seniors and 58 percent of other adults rely on a prescription medication on a regular basis. Among children, a 2009 survey found that 56 percent had used at least one medication in the previous week, and most of those were over-the-counter products (Pediatrics, August 2009).

With the goal of addressing this problem by strengthening the regulation of the manufacturing process for drugs, Community Catalyst supports Sen. Bennet’s legislation and is working to educate and assemble national and state groups to do the same.

– Jessica Hamilton, Program Associate