Instead of alerting the FDA and issuing a recall after discovering a quality problem with batches of Motrin, Johnson and Johnson hired contractors to go and buy up batches of the drug, instructing them to pretend to be regular customers and not to mention the word “recall.”

The House Committee on Oversight and Government Reform used this startling story in a hearing yesterday to illustrate and further probe the major quality and compliance problems that led to a massive recall of 136 million bottles of children’s medications last month.

At the hearing, Chairman Edolphus Towns (D-NY) and Ranking Member Darrell Issa (R-CA) pledged to introduce bipartisan legislation to give the FDA mandatory recall authority and additional powers to oversee drug safety issues. “One thing we know now is that the FDA needs mandatory recall authority,” Chairman Towns said. “They should not have to persuade a company to recall suspect products.”

The committee heard from both FDA Deputy Commissioner Dr. Joshua Sharfstein and Colleen Goggins, head of consumer products at J&J, which owns the division that made and recalled the drugs.

Sharfstein said that as the manufacturing problems go, those discovered at J&J were serious, and that the company’s delay in alerting the FDA was “deeply worrying.” Inspections of the now-closed plant Pennsylvania plant revealed that raw materials used in making the drugs had particles of nickel, chromium and cellulose, and some were contaminated with gram negative bacteria. Though batches using the raw material were not shipped, FDA said that the company shipped other parts of that lot, and did not do adequate testing to ensure their safety.

Asked about the authorities and resources the FDA needs to better safeguard the drug supply, Sharfstein frequently referred to the additional authorities in the pending food safety bill, which would give the agency authority to issue mandatory recalls, access company records, and assess civil penalties. (An FDA official said the J&J case had been referred to its office of criminal investigation.)

“This is a company that had a major problem with compliance,” Sharfstein said, “and I think in this case we did really call them to account for it.”

Thought the J&J plant is domestic, Rep. Issa (R-CA) rightly suggested that the incident raises larger questions about the safety of overseas manufacturing and imports, which are on the rise.

“I’m deeply concerned,” he said in his opening statement,  “that J&J is the tip of the iceberg. If one of the most reliable and responsible organizations in America and a company with a great connections to the community can fail us, then what about those aspirins and other products that are more and more being imported from outside our country, from factories that are harder to reach. […]?”

Community Catalyst and Pew Prescription Project are concerned with these questions too, and support solutions that will shore up manufacturing safeguards and oversight in foreign and domestic plants.

While the chance that the contaminated batches caused illness was remote, Sharfstein said that the problem was a serious one and that the agency continues to look. “We consider these quality problems to be quite significant,” he said, “and want to fix them before it comes to the point where we’re counting the problem in hospitalizations and injuries, instead of bottles recalled.”

–Kate Petersen, PostScript blogger

Tomorrow the House Committee on Oversight and Government Reform hears from FDA and Johnson & Johnson officials on the May 1 recall of more than 40 types of popular brand-name children’s medicines by McNeil, a division of the drug giant.

The recall–which affected 70 percent of the kids’ liquid meds market in the U.S., including common brands such as Tylenol, Motrin, and Benadryl–came after the company reported more than 40 consumer complaints about foreign materials in the medicines between June 2009 and April 2010, when an FDA inspection of the plant in Fort Washington, Pennsylvania turned up raw materials that were contaminated with gram-negative bacteria.

According to Reuters, a Committee document released yesterday said that the Food and Drug Administration does not consider the 775 reported adverse events a “spike” and there is no “clear pattern” indicating the problems were caused by the recalled products.

It’s still not clear what country the contaminated raw materials found in the Fort Washington plant came from, or whether that supplier was ever inspected by the FDA.

Committee members should find out how often inspections are done on plants that make over-the-counter meds, and whether there are plants that are skipped entirely. There was a big gap between the time the company reported receiving its first consumer complaints and the FDA inspection this April—Congress should find out why. And investigators should dig deeper on FDA’s lack of recall authority: Can an agency charged with protecting the public’s health really do so if it can’t force a company to recall contaminated drugs?

Other members of Congress concerned with drug  safety are getting in on the act, too. As we wrote here last week, Rep. Rosa DeLauro (D-CT) is looking into the recall, asking whether FDA inspections and recall authority match the demands and risks of the U.S. drug supply.

And this week, Senate HELP Committee chair Tom Harkin (D-IA) wrote to the FDA, asking for info on the company’s suppliers and quality controls. While neither DeLauro nor Harkin have announced hearings yet, the recall and these inquiries spurred FiercePharma to pose a question of its own:

This isn’t the first time we’ve heard that question about FDA empowerment; could this highly public manufacturing mess-up lead to legislation?

–Kate Petersen, PostScript blogger

New proposed rules from the NIH yesterday on preventing conflicts of interest in biomedical research improve public disclosure but leave the decision about what constitutes a financial conflict with an investigator’s institution. The rule lines up with much of Community Catalyst and Pew Prescription Project’s recommendation to the agency in July 2009. The Institutes are again seeking public comment for 60 days.

The proposed rules require investigators – that is, anyone involved with the design, conduct or reporting of publicly-funded research – to disclose to their institution all payments greater than $5000. Those payments include consulting, honoraria, speaking or travel funds, or paid authorship. The institution – commonly an academic medical center or university—must then determine what is a potential conflict and report those payments and a management plan to the NIH.

This is a shift from the current rules, which require an investigator to disclose payments to her institution only if she believes it conflicts with her research – a system, it seems, that left too much room for interpretation. News reports have documented millions of drug company dollars that went to investigators running trials on drugs made by those companies. (GoozNews has about a complete a list of news clips as one could want.)

The proposed rule also requires each institution seeking NIH funding to establish a publicly accessible website on which it would post its conflict of interest policy and all financial conflicts of interest held by investigators, updated at least annually. This is a great step toward better transparency that is meaningful to patients and consumers, as it will provide an important crosscheck to the Sunshine database and other disclosure websites for assessing conflicts and compliance.

We’d still like to see payments below $5000 be disclosed to institutions – the number is arbitrary, and studies suggest gifts and payments much lower than that can create bias.  Though the NIH cited concern over administrative burden, many institutions and companies have already begun requiring disclosure at a much lower threshold, suggesting it’s important, and doable.

And the big increments that NIH set for public disclosure on the websites (less than $20,000, less than $50,000, less than $100,000 or more than $250,000) leave too much guesswork. There is a difference between a $250K relationship and one in the millions, but the public won’t be able to see that if the proposed rule stands as is.

The nature of academic-industry relations has changed dramatically in recent years, and it’s encouraging to see that the NIH rules get that—and account for it. For instance, the NIH addressed the shift in industry-backed CME by making explicit that payments for lectures, seminars, and speaking gigs sponsored by non-profits are not exempt from disclosure, acknowledging that for-profit companies often create non-profit arms to fund talks and execute programming. And they added “paid authorship” and “travel reimbursement” to the list of examples of payments to acknowledge industry’s heavy reliance on speakers’ bureaus, backing researchers to attend or present at conferences, and ghostwriting – or soliciting an academic to sign an article that was not written by her/him in full:

With regard to “paid authorship”, in particular, although there should be little question that receipt of payment from an entity in exchange for the drafting of a publication constitutes payment for services, we believe it is important to reference this form of payment specifically in the regulations.

Read more about our original comments to the NIH here, or read the proposed rule at the Federal Register.

–Kate Petersen, PostScript blogger

More calls for shoring up safety gaps in the safety of the U.S. drug supply came from the Hill this week in the wake of a wide recall of children’s medicines. Congresswoman Rosa DeLauro (D-CT), a frequent advocate for better drug and food safety, has joined those in Congress seeking answers to McNeil Healthcares’ latest batch of recalls.

The Congresswoman has asked about the FDA’s role in inspecting plants and whether it needs better recall authority after McNeil, a division of Johnson & Johnson, pulled 43 types of children’s Tylenol, Motrin, Zyrtec, and Benadryl from the shelves last week. The recall came after the company reported 46 consumer complaints between June 2009 and April 2010 about foreign materials and dark specks in the medicines, and an FDA inspection of the plant in Fort Washington, Pennsylvania turned up raw materials that were contaminated with gram-negative bacteria.

In a letter addressed to FDA Commissioner Dr. Margaret Hamburg, Rep. DeLauro expressed concern that the agency does not have adequate authority to recall drugs (it can only suggest, but not enforce, a recall).“What can be done to enhance the agency’s ability to effectively monitor drug production and actual practices at domestic facilities?” she wrote to Dr. Hamburg.

DeLauro also inquired into the FDA’s system for ensuring that all consumers receive recall information, and its authority to address potentially criminal corporate actions.

Last week, the House Committee on Oversight and Government Reform began a bipartisan investigation into the origin of the J&J recall.

Concerns in Congress about the quality safeguards in the U.S. drug supply have been mounting, and the latest recalls point to how widespread the effect of a manufacturing problem in such a globalized supply chain can be: news reports suggest that the recall affected 70 percent of the U.S. market in over-the-counter liquid medications for children.

In March, a House hearing on drug safety highlighted gaps in the system for safeguarding the U.S. drug supply–gaps which may have exacerbated the heparin contamination in 2008, and recalls like Johnson & Johnson’s.

This is the company’s fourth recall in seven months.

Visit the Pew Prescription Project for more on improving the safety of the U.S. drug supply.

–Kate Petersen, PostScript blogger

photo credit: Wikimedia Commons

For those who haven’t read it, Ed Silverman over at Pharmalot has a great interview with former FDA associate chief counsel and former Pfizer senior counsel Arnie Friede, about the new “BadAd” program that FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) rolled out yesterday.  The program gives doctors and health care providers a way to report misleading or illegal drug promotion to the agency, which has not, until now, had a mechanism for reviewing promotion that happens in the doctor’s office, off the page or TV screen.

When Silverman asked how an already resource-strapped FDA would follow up on every report, here’s what Friede said:

On balance, the FDA probably feels there’s a lot of violative behavior they simply can not monitor with limited resources. To some extent, yes, many of these reports may reflect a doctor’s misunderstanding of what was actually said. That’s certainly a possibility and, hopefully, the FDA willl find a reasonable way to separate the wheat from the chaffe. But if the objective is compliance and not enforcement, then this is an additional incentive for a company to closely monitor and control communications by their sales people. For an enforcement agency, I think it’s an understandable, perhaps even brilliant move…

Read the whole thing here.

-Kate Petersen, PostScript blogger

Roughly two-thirds of patients believe it’s important to know a physician’s ties to a pharmaceutical company, and between 27 percent and 56 percent believe that such ties affect prescribing. Those are some of the findings from a systematic review in the current Archives of Internal Medicine that looked at 20 surveys of patients, research participants and medical journal readers about the impact of financial ties physicians and researchers have with the pharmaceutical industry.

That two-thirds finding – and a study last year suggests that number may be much higher (84 percent wanted their physicians to disclose relevant financial ties to them) – syncs up with the findings of a 2008 nationwide survey (pdf) we conducted: 64 percent felt that it was important to know if their doctor had a relationship with a drug companies. But less than half said they would be likely to ask their doctors about this.

That makes sense. Setting aside the mores around talking about money and mystique associated with the medical profession, the doctor-patient relationship is characterized by an inherent power imbalance: the sick come before one who understands and can treat their condition. So it’s unsurprising that patients are hesitant to ask their doctor whether he or she did a lunch and learn for Lipitor last month.

That’s one reason the Physician Payments Sunshine Act, which passed with national health reform, is so important. The Sunshine Act, which will create a national public website into which drug and device companies must report payments and gifts made to physicians, will allow consumers to access the information they and much of the medical community have deemed relevant to clinical care—without requiring them to obtain it in by asking cold in the exam room.

The authors of the Archives study made this Sunshine connection, highlighting the significance of their findings for those charged with designing and implementing the disclosure database:

[W]e find that, across multiple studies, patients and research participants are able to distinguish between different types of [Financial Ties] as well as the relative importance of disclosure of each. Public reporting systems should be designed to maximize consumer understanding, with an emphasis on clear and straightforward presentation of those FTs that stakeholders care most about.

That’s right.  But that doesn’t mean it will be easy. As we’ve pointed out here, much-touted voluntary (and often court-ordered) company disclosure data has been hard for researchers and the public to navigate or extract—and each company system is marked by unique loopholes that limit the usefulness of the data.

In an accompanying editorial (subscription required), Eric Campbell, a Harvard researcher who has written extensively on physician-industry relations and served on the Institute of Medicine committee that produced last year’s conflict-of-interest report, wrote:

In order for consumers to use the data, it is clear that the quality of the data that is reported by companies must be improved. The early experiences from Minnesota and Vermont, which have the longest history of making physician-industry relationship data available, suggest that the details are important in making this information useful.

Campbell says that means establishing real auditing capabilities, meaningful penalties for non-compliance, and adequate funding to support data collection and reporting.

–Kate Petersen, PostScript blogger