The special health issue of The Hill has a prescription for ensuring U.S. drug safety.  This op-ed on why Congress must end the inspection disparity between U.S. pharmaceutical plants and foreign drug makers is a must-read for every lawmaker and the consumers of the 4 billion prescriptions filled last year.

Every day, millions of Americans take medicines approved by the U.S. Food and Drug Administration (FDA), bearing the name of some of our nation’s best-known pharmaceutical companies, and prescribed by health care providers. Yet, what most Americans don’t know is that, for most of these drugs, their components were manufactured in facilities that may have never been inspected by a government agency. “In fact, according to a U.S. Government Accountability Office (GAO) report, at least 80 percent of the ingredients in U.S. drugs now originate overseas.  And this could be real cause for concern,” according to the article’s authors, Patricia Benson and Allan Coukell.

The migration of pharmaceutical manufacturing to low-cost countries with low regulatory oversight, such as India and China, may promote counterfeiting, adulteration or other corner-cutting failures to meet quality standards.  This scenario occurred with the adulteration of heparin in 2007. The results were devastating as Benson and Coukell noted: “The FDA would eventually receive reports of 574 Americans who suffered symptoms associated with this tainted medicine, some of whom died, over a three month period in early 2008 – a clear breach of the U.S. supply chain.”

Two key lessons that should be learned from heparin are spotlighted in The Hill piece:

• First, Baxter did not conduct its own audit of the Chinese supplier until three years after they began contracting with this firm. U.S. drug makers must be held accountable for the contractors they choose. They must demand that their foreign suppliers meet the FDA’s rigorous standards— even if it means conducting a meaningful investigation before adding contractors’ goods to a pharmaceutical supply chain.
• Second, the FDA approved the Chinese supplier of heparin without conducting a pre-approval inspection in part because the contractor had a name similar to another supplier in the agency’s database. This example, and others like it, indicates that to provide ongoing oversight of the industries and technologies it regulates, the FDA must modernize old and error-prone databases. In addition, the FDA needs to conduct more inspections of foreign plants that supply drugs and pharmaceutical ingredients for U.S. use. Unfortunately, the agency lacks the resources to visit overseas manufacturing sites with any meaningful regularity.

Now the question is whether Congress is listening.

– Marcia Hams, Community Catalyst Director of Prescription Access and Quality

The buzzword at a Sept. 14 hearing on securing the pharmaceutical supply chain was one not often heard in the current congressional climate: “consensus.” There was general agreement among witnesses that our laws are outdated in a world where the drug supply chain stretches around the globe through a network of suppliers in countries such as India and China.

In 2007 and 2008, the pharmaceutical industry and regulators got a wakeup call when a batch of the blood thinner heparin was adulterated by a Chinese manufacturer, sickening and even killing American patients who took it.

“I believe that adulterated drugs coming into this country is criminal. I think it’s a form of murder,” said Sen. Barbara Mikulski of Maryland. “So we’ve gotta get real, we’ve gotta get serious, and we have to have a sense of urgency.”

The hearing, organized by the Senate Health, Education, Labor and Pensions Committee, is a part of lawmakers’ fact-finding effort for the 2012 reauthorization of legislation on drug user fees.

In testimony, the Generic Pharmaceutical Association supported Health and Human Services Secretary Kathleen Sebelius’ call for congress to update the U.S. Food and Drug Administration’s authorities.

“GPHA is in agreement with the secretary and FDA that it is essential to modernize the laws governing the U.S. supply chain,” Gordon Johnston said. “As noted in my opening remarks, the responsibility of ensuring safety is a shared one that rests with all of us in industry and not just FDA.”

Johnston also referenced the Pew Health Group’s report, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs:  “As my colleagues at Pew noted in their recent report, it’s also critical that manufacturers continue to go beyond good manufacturing practices and assure that their supplier qualification tools are used as well as a risk based assessment to assure the quality and integrity of suppliers abroad.”

In his testimony, Allan Coukell, director of medical programs at Pew Health Group used a photograph of a factory in squalor to demonstrate the horrible conditions of facilities where some drug ingredients are manufactured.

“A couple of speakers have mentioned the need for manufacturers themselves to ensure supplier quality. That’s crucial,” Coukell said. “Sometimes substandard facilities sell to so-called “show” factories – a high-quality facility that sells product that it did not make itself.”

Coukell quoted a China-based pharmaceutical auditor who said American and European companies are misinformed about the identity of all, or part, of their supply chain more than a third of the time.

Potential solutions discussed included strengthening industry quality management, increasing regulatory oversight, and making sure the FDA has the tools it needs, such as the ability to order the recall of drugs.

Sen. Michael F. Bennet of Colorado noted how the testimony at the hearing reflected the notion that updated policies are a necessity.

“I find remarkable the degree of consensus around a lot of the issues we face,” Bennet said. “The lack of a regulatory regime that reflects reality is bad for our consumers and bad for our business. I think that’s why we need to be urgent in fixing it.”

– Marcia Hams, Community Catalyst, Director of Prescription Access and Quality

As more payment data from drugmakers to physicians went public this week, it seems that both industry and doctors are easing off the gas in promotional speaking and other marketing-related payments. With Propublica data, the Boston Globe compared several companies’ payments to Massachusetts providers in 2009 and 2010:

Eli Lilly and Co., one of the nation’s largest drug makers, paid health care providers here $866,919 in 2010 for speaking about their drugs, a 46 percent drop from 2009, according to an analysis by the Boston Globe and ProPublica, a nonprofit online investigative journalism organization. Payments from GlaxoSmithKline fell at least 29 percent to $884,850, and probably more because the company’s 2009 data did not include the first quarter.

And Propublica showed that payments by Cephalon, one of the companies required to disclose payments under a corporate integrity agreement with the U.S. Department of Justice, dropped from almost $9.3 million nationally in 2009 to $5 million last year.

But $5 million — part of the $220 million paid to providers last year by just eight companies — is still a chunk of change for an industry that’s owed billions of dollars over the last five years for illegally marketing to docs and is still struggling to reinvigorate its pipeline.

And though many medical schools around the U.S. have barred or limited faculty members from joining pharma speakers bureaus out of concern that the practice (in which physicians are paid to deliver company-generated talks to other doctors) creates bias or the appearance of it, some providers are still very willing to sign on. Pain physician Jeffrey Gudin from New Jersey,  a speaker for J&J last year, talked to the Star-Ledger.

“I support education from any source,’’ Gudin told the Star-Ledger, “even when it’s pharmaceutically funded.’’

And even, one might note, when that pharma-funded “education” is supporting him back.

But as trends go, hard and fast correlations here are murky to untangle, mostly because the data is a very incomplete set – different amounts and categories of payments are publicly available only from about 12 of the more than 70 drug makers that market in the U.S.

The Globe and Propublica stories today point to some other complicating factors: the shift from a largely in-person marketing game to one focused more and more around online and electronic interaction with prescribers; industry contract and conference cycles that may skew comparisons of quarter-by-quarter financials; the disinfecting disincentive for a physician to be publicly linked to a company’s marketing team; and companies’ own efforts to make sure they’re being recognized for their innovation and legitimate scientific collaborations, not for their speakers bureaus.

From the data in Massachusetts, it does seem like a combination of stronger conflict of interest policies at the leading medical schools and teaching hospitals there, as well as the state’s own disclosure law, may have combined to reduce the number of physicians willing to sign on to drug companies’ payrolls, or the amount companies are willing to pay those who do.

But as Allan Coukell of the Pew Health Group pointed out to the Star-Ledger, this database of court-ordered and voluntary disclosures is still only a fraction of the story — a few frames of a much larger picture we’ll need Sunshine to develop.

–Kate Petersen, PostScript blogger