Posted today by the PostScript blog at Community Catalyst:

Posted on: August 4, 2010; 11:53 am

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

You may view the latest post at: http://postscript.communitycatalyst.org/?p=1549

(The following blog was posted yesterday on Community Catalyst’s Postscript blog. It highlights an exchange between FDA Deputy Commissioner Joshua Sharfstein an Congressman Dingell concerning the need for increased FDA authority and resources to effectively regulate drug safety.)

Drug Safety: A Duet

March 11th, 2010

Yesterday, the House Energy and Commerce Subcommittee on Health heard from FDA Deputy Commissioner Joshua Sharfstein on the safety of the drug supply and current agency practices to ensure the safety of marketed drugs.

Sharfstein, who has been a strong advocate for drug safety, both at the agency and previously  as health commissioner in Baltimore, made a forceful case for what FDA needs to keep drugs safe: “FDA needs additional tools to move our oversight capabilities into the 21st century.  FDA needs to access regulatory information quickly, hold all parties responsible for the quality of products in the supply chain, and have reasonable and reliable options for enforcement,” he said.

The hearing was notable for the bipartisan consensus that securing the safety of the drug supply is a national priority with high stakes, and unanimous agreement that the FDA’s ability to ensure that safety must be shored up. It convincingly framed drug safety as an equally urgent next step to a food safety measure that passed the House by a wide margin last year.

But perhaps the hearing’s most compelling arguments for a safer drug supply came in this stage-worthy exchange between Sharfstein (JS) and Chairman Emeritus John Dingell (JD), who has worked to support the agency’s drug safety efforts for much of his recent career.

JD: Dr. Sharfstein, I want you to understand these are friendly questions. I want yes or no answers. You are familiar with the heparin crisis, which caused 81 American deaths. Does FDA currently have the adequate resources, personnel, and authorities to prevent another heparin crisis?

JS: No.

JD: Do you have the ability to control the safety of imported pharmaceuticals?

JS: Not to the extent we’d like.

JD: Do you have the authority and resources to address the safety of components being now imported into this country?

JS: No, not to the extent we’d like.

JD: Do you have authorities and resources to see to it that good manufacturing practices (GMPs) are properly observed overseas?

JS: Not to the extent we’d like.

JD: Would you please submit to the committee the number of people that you have at the different ports to ensure the safety and the inspection of pharmaceuticals coming into this country, and also would you give the number you need to see that this is done. Please submit that for the record.

[JS assents]

JD: Do you have adequate authority to keep out unsafe drug shipments at the border?

JS: No.

JD: Do you have authority to require manufacturers to ensure the safety of their supply chain?

JS: No.

JD: Do you have the authority to see to it that GMP are observed in this country on both food and drugs, and abroad? Yes or no?

JS: No, not to the extent we’d like.

…
JD : Do you have adequate authority to require mandatory drug recalls?

JS: No.

JD: Do you need that authority?

JS: We would like it that authority, yes.

JD: Would you like it or do you need it?

JS: I’d say we need it.

JD: [refers to the Food and Drug Administration Globalization Act of 2009 and its cosponsors] [FDAGA] would give you significant authorities to address your current lack of capabilities?

JS: That legislation has very important elements, yes.

JD: It would also give you the [financial resources] you need by enabling you to collect fees from both manufacturers of food and pharmaceuticals? Is that right?

JS: It does have that provision, yes.

JD: And you can do that both at home and abroad, is that right?

JS: I believe so, yes.

JD: Are those resources and fees included in your budget submissions to the Congress?

…

JS: For food it is.

JD: How about pharmaceuticals?

JS: I don’t believe so, no.

JD: Now it’s a curious situation I’ve observed, that you are in the awkward place at FDA of having somebody be able to bring unsafe foods into the United States, and you can’t catch them at the point of entry. But you also have the problem that if you do catch them, you don’t have authority to seize, impound or to destroy. Is that right?

JS: Yes.

JD: So you send them back out?

JS: I believe so. Often that’s what happens.

JD: And they then often bring them back in, through another point of entry?

JS: I think they can try, yes.

JD: Do you have that same problem with pharmaceuticals?

JS: Yes.

JD: So that problem exists in both places. So you have problems with unsafe commodities being brought in—foods and pharmaceuticals. You also have some that are over-aged, improperly stored, contaminated, filthy, improperly packaged. Counterfeit. And you also have some that are full of inert substances, you mentioned talcum powder…Do you have authority to deal with those?

JS: We have some authorities. But not–

JD [interrupts] Do you have enough?

JS: We don’t have enough.

JD: As proven by heparin.

JS: Yes, in part.

JD: And you have coming into this country from China on a fairly regular basis—and from Mexico and other places—unsafe food and pharmaceuticals. I can recall mushrooms. I can recall berries. I can recall tomatoes and jalapeno peppers. I can recall the heparin scare. And a large number of others. This is an ongoing and continuous problem, is it not?

JS: Absolutely.

JD: And you lack the Congressional support, both in authority and money, to do the job that you need to do to protect the American people? Isn’t that right?

JS: Well, we very much want to do more.

JD: I don’t want you to be afraid to say that we haven’t given you  the authority you need—

JS:  No we want more authority—

JD: —If it’s the truth, because we’re going to try to get it for you.

–Kate Petersen, PostScript blogger