Congress is attempting to formulate and pass legislation to address problems that have become apparent at the Food and Drug Administration (FDA). After increasing questions in recent years about the safety of prescription drugs and imported food, we've learned about the limited ability of FDA to regulate effectively some of the products.

Legislation in Congress, particularly in the House Energy and Commerce Committee, that addresses ways to reform how FDA protects us from harmful products in the marketplace is being strongly opposed by lobbyists for the food and drug industries. According to an article in POLITICO, the lobbyists are trying to delay the legislation and run the clock out in this abbreviated election year session of Congress.

One of the lobbying groups active in the fight is the Grocery Manufacturers Association (GMA). It represents agribusiness and food processing companies. GMA last year put forth its own proposal calling on FDA to adopt a foreign supplier quality assurance program after FDA announced an import ban on five different types of Chinese farm-raised seafood products. Apparently, GMA thinks Congress wants to go too far in moving to protect consumers at the expense of its members.

The Energy and Commerce Committee seems undeterred, according to POLITICO: "Our plan is still to do a comprehensive overhaul of FDA to equip it to deal with an increasingly globalized market," said spokeswoman Jodi Seth. "We're interested in cleaning up the whole mess, including contaminated heparin and tainted tomatoes. Consumers want all the products they consume to be safe."

It may not be easy to get anything meaningful passed to enhance FDA's powers this session, but one would think the lobbyists would be less resistant to getting a bill completed this year — while they still have their friend in the White House.

Late last week, FDA's lead scientist asked the agency's science board to convene a subcommittee to study the effects of bisphenol-A (BPA), a chemical commonly found in hard plastics and food containers. The science board is an advisory committee of non-governmental scientists who provide expert advice to FDA decision makers.

From the FDA press release, it appears as though the primary responsibility of the subcommittee will be to review an FDA task force report on BPA exposure and effects. "In April 2008, the FDA formed an agency-wide BPA Task Force to facilitate review of current research and new information on BPA," FDA says. After the subcommittee reviews the report this summer, "the task force will make recommendations" to the FDA commissioner.

The increased activity at FDA comes less than two months after a report by the National Toxicology Program (NTP), which, like FDA, is part of the Department of Health and Human Services, raised concern about the possible health effects of BPA.

The NTP report finds most humans are exposed to BPA and retain it in their bodies. The panel looked at studies of laboratory rodents exposed to BPA and found a wide variety of adverse health effects at high doses and other possible health effects at low doses — mostly developmental and reproductive abnormalities.

NTP concluded bisphenol-A is of "some concern" — a qualitative designation. Other options available to the panel included "serious concern" and "concern" for riskier substances, and "minimal concern" and "negligible concern" for less risky substances.

But FDA, which, unlike NTP, has the authority to regulate the chemical, isn't so sure. FDA has said on past occasions that BPA does not pose a "safety concern at the current exposure level."

A renewed effort within the agency to study BPA is a wise move, as is the decision to seek review from the agency's independent science advisors. FDA says its agency investigation will consult the NTP report as well as "available information on BPA in numerous other risk assessment documents from scientific and regulatory bodies worldwide."

Let's hope FDA keeps its pledge to limit its search to work from "scientific and regulatory bodies." In the past, FDA has relied on industry studies, according to congressional investigators. The House Energy and Commerce Committee wrote to FDA in January asking the agency to identify the basis on which it has made its decision that BPA is not harmful. FDA identified two studies, both of which were funded by the American Chemistry Council. One study had never been published or subjected to peer review.

Reg•Watch Update: "FDA Would Regulate BPA If Found Harmful, Official Says"