An article in today's New York Times follows up on the controversy of another botched FDA drug approval (Avandia). With an unfortunately large number of case examples to study, drug safety experts and lawmakers are beginning to come to a consensus on the nature of the problem at FDA.

Common sense would tell us that drug safety and drug approval are inextricable issues. In reality, this is not the case. The Times article discusses how safety is marginalized in the name of expeditious approvals. The resulting organizational culture at FDA is leading to safety mishaps, not to mention some bad blood:

[A Congressional] hearing next week may highlight the growing internal dissension between officials who approve drugs and those who track the safety of drugs after they have been approved. Tension between the groups has long been common, but in recent months it has erupted into sniping.

Congressional investigators said the safety group recommended months ago that the drug agency put its severest warning on Avandia. The review group, which holds sway, has not done so.

Sen. Chuck Grassley (R-IA) attempted to attach a provision to the Senate's recent FDA reform bill which would have addressed this issue. The Grassley amendment would have involved the Office of Surveillance and Epidemiology (safety folks) in post-market safety reviews, instead of leaving all the responsibility to the Office of New Drugs (approval folks). The amendment was rejected 47-46.

There is still a chance for such legislation when the House tackles FDA reform this summer. America needs an FDA focused on proving safety first, not presuming safety first. Stay tuned to Reg•Watch for more.

David Michaels at The Pump Handle blog pointed out this incredible piece of news from the Associated Press.

A Chinese court has sentenced to death the former head of the State Food and Drug Administration Zheng Xiaoyu. Zheng, roughly the equivalent of the U.S.'s FDA commissioner, was convicted of taking bribes which ultimately led to the approval of pharmaceuticals with deadly side effects.

Capital punishment is a grave overreaction. Nonetheless, China's food and drug safety record has been atrocious and is beginning to leech into the United States. The AP article rattles off a number of recent food contamination scares originating in China (pet food, toothpaste, monkfish and catfish).

China's top drug regulator gets death sentence [AP via MSNBC]

Earlier today, Reg•Watch blogged about a Congressional gaff in which lawmakers continued to allow the Department of Homeland Security to trample on the rights of the individual states to promulgate chemical security rules stricter than those of the federal government.

Today, four workers' unions and six public interest groups (including OMB Watch) sent a letter to lawmakers calling for new, comprehensive chemical security legislation. The proposal includes language which would eliminate DHS's ability to preempt state regulations.

Read the letter here.

Yesterday, Congress missed an opportunity to restore states' ability to impose standards stricter than federal standards on chemical plant security.

As OMB Watch reported in April, the Department of Homeland Security finalized interim regulations for instituting security performance standards at high-risk chemical facilities. The regulations fail to protect the public on a number of fronts.

Of particular concern is a controversial provision which allows DHS to preempt state rules. Although the DHS rules are temporary, and many states' rules are permanent, DHS could essentially terminate state programs. As OMB Watch and Public Citizen said in comments on the rules, "DHS's chemical security regulations should be viewed as a floor, not a ceiling."

Yesterday, the House and the Senate passed legislation to provide supplemental funding for the war in Iraq. The bill had included language which would have fixed the preemption problem. However, Congressional leaders stripped the language at the behest of the National Association of Manufacturers, according to The New York Times.

Ultimately, America needs comprehensive chemical security legislation that will force DHS to implement strong standards and prevent it from getting in the way of the states. When it comes time for Congress to act, let's hope lawmakers don't once again bow to the wishes of industry.

Yesterday, OMB Watch submitted comments on FDA's proposed conflict of interest guidelines for agency scientific advisory panels. Avoiding conflicts of interest on these panels is important to ensuring scientific integrity, responsible use of agency resources, and strong final regulatory actions.

OMB Watch complements some provisions in the proposed guidance, but also encourages FDA to close certain loopholes which undermine its intent. As stated in the comments, "OMB Watch is concerned the draft guidance creates loopholes and does not reflect the spirit of impartiality in regard to the identification of the need for a unique individual to serve on an agency advisory committee."

Click here to read OMB Watch's comments.

Click here to read OMB Watch's detailed analysis of the proposed guidance.

As Reg•Watch blogged earlier, Democratic Sens. Dick Durbin (IL) and Bill Nelson (FL) sent a letter to President Bush asking him to withdraw the nomination of Michael Baroody for commissioner of the Consumer Product Safety Commission.

Separately, Nelson has threatened to put a hold on the nomination if Bush does not withdraw it. This would prevent the Senate from voting on Baroody.

A hold could have unintended consequences. As Reg•Watch blogged months ago, CPSC is operating without a voting quorum due to the commissioner vacancy. Sen. Mark Pryor (D-AR) attached to an unrelated Senate bill (S. 4) language which would extend the quorum for six months. However, the bill is stuck in conference negotiations with the House.

While the lack of a quorum does not prevent CPSC from performing its day-to-day work (most recalls are voluntary measures by manufacturers), the Commission is currently powerless in promulgating new regulations.

Baroody's industry ties make him an inappropriate choice for CPSC commissioner. But America needs a fully-functioning product safety agency.

Senate leadership and the White House need to get together and hash this out. For the reasons mentioned earlier, Baroody's nomination is already dead in the water. The White House should offer a more palatable choice, and the Senate should push to confirm the nominee in order to restore the functionality of the CPSC.

On March 1, President Bush nominated Michael Baroody to be a commissioner on the Consumer Product Safety Commission (CPSC). Many have criticized the nomination because of Baroody's record of opposing safety regulation in his role as a lobbyist for the National Association of Manufacturers (NAM).

Yesterday, Sens. Dick Durbin (D-IL) and Bill Nelson (D-FL) sent a letter to President Bush asking him to withdraw the nomination. In the letter, the Senators really brought their A-game, citing statutory criteria for the qualifications of a CPSC commissioner:

Specifically, Section 4(a) of the [Consumer Product Safety Act] states: "In making such appointments, the President shall consider individuals who, by reason of their background and expertise in areas related to consumer products and protection of the public from risks to safety, are qualified to serve as members of the Commission."

There is no evidence in Mr. Baroody's professional background to indicate that he meets these criteria. To the contrary, Mr. Baroody has worked against the "protection of the public from risks to safety" in his work for [NAM].

In the letter, we also find out that Baroody received a $150,000 severance payment from NAM. Due to ethics rules, Baroody would likely have to recuse himself from CPSC decisions involving NAM or NAM member companies. According to the NAM website, the trade organization represents thousands of manufacturers. That would mean a whole lot of recusing for Baroody.

Currently, the Senate Commerce Committee has scheduled a nomination hearing for May 24. Check back with Reg•Watch later today for more on the Baroody nomination.

Reg•Watch Update: Beneath the Politicking, a Powerless CSPC

As Reg•Watch has reported, the Mine Safety and Health Administration (MSHA) has been absolutely abysmal in enforcing the MINER Act. Congress passed the MINER Act in the wake of the Sago and Darby mine tragedies and included some statutory deadlines. MSHA has failed to promulgate any meaningful standards related to the MINER Act.

Rep. George Miller (D-CA) has been displeased with MSHA and yesterday his committee, the House Education and Labor Committee, held an oversight hearing.

But the blame should not fall entirely to MSHA. J. Davitt McAteer, a former MSHA administrator and current VP of Wheeling Jesuit University (go Cardinals!), spoke of the muddied waters of our federal regulatory system:

In the best of circumstances, promulgating a new health or safety standard takes 2-3 years to complete. However, when the rule was substantial and/or controversial, it can take 4, 6, 8 or more years from start to finish. In the worst of cases, the procedural maneuvering completely obstructs the process…

The public policy considerations embodied in the Federal Administrative Procedure Act, Presidential Executive Order 12866, the Paperwork Reduction Act of 1995, the Information Quality Act of 2001, and their amendments and implementation documents as well as other requirements have suffocated the public health and precautionary values embodied in the statutes governing, among others, MSHA and OSHA. The harsh reality is that those interest groups, which have a stake in avoiding or postponing new workplace rules, have the financial resources and political clout to impede and/or bog down the current rulemaking system.

Wednesday, the Senate voted 93-1 to pass S.1082, The Food and Drug Administration Revitalization Act. The two primary aims of the legislation are to renew the Prescription Drug User Fee Act and to generally strengthen the regulatory authority of the FDA.

Renewing PDUFA

The legislation would renew and expand (by about 33 percent) the FDA's user fee program whereby pharmaceutical companies pay for safety reviews of new drugs. The current PDUFA program is set to expire Sept. 30. If PDUFA renewal is not signed into law by July, FDA has said it will begin warning drug-review staff of potential layoffs.

The user fee program is a peculiar process. While the payments are an important source of funding for FDA, the program allows drug companies to negotiate with FDA the process for a drug's approval (particularly the speed of approval). The strings-attached approach gives drug companies far too much influence in safety reviews

Strengthening FDA's Regulatory Authority

If signed into law the bill would:

• Strengthen FDA's authority to require drug companies to perform post-market safety reviews
• Provide FDA the authority to force drug companies to change drug labeling
• Create a new database allowing FDA to collect information on adverse health effects related to drugs already on the market
• Provide FDA the authority to fine drug companies for false or misleading direct-to-consumer advertising
• Expand a program rewarding drug makers who study adverse effects of drugs on pediatric health
• Require FDA to establish labeling standards for pet food and a process by which pet food can be recalled

A number of amendments received close votes on the Senate floor. Stay tuned for a recap of that action later on.

Reg•Watch Update: Senate FDA Reform Bill: Amendment Frenzy

The Mine Safety and Health Administration has released a report citing lightning as the cause of the Sago mine disaster which killed 12 miners, according to The New York Times.

As OMB Watch reported in March, the United Mine Workers of America (UMWA) claims friction within the mine caused the explosion. UMWA President Cecil Roberts called the MSHA report "far-fetched."

UMWA has blamed MSHA and the mine's owner for conditions which made Sago susceptible to such a horrific explosion. Claiming an "act of God" such as lightning would certainly reduce the culpability of the owner and federal regulators. This controversy is still far from settled.

Moments ago, the Senate voted 93-1 to pass S. 1082, The Food and Drug Administration Revitalization Act. The two primary aims of the legislation are to renew the Prescription Drug User Fee Act and to generally strengthen the regulatory authority of the FDA.

The House will take up similar legislation in the coming weeks. President Bush has threatened to veto the legislation if it includes a provision allowing the importation of cheap drugs. As Reg•Watch reported yesterday, the Senate bill does include such a provision, but it was rendered useless by another amendment which requires an approval process too onerous for FDA to ever handle. Subsequently, the White House is now saying Bush is unlikely to veto the bill if it were to cross his desk in its current form, according to BNA news service (subscription). Stay tuned to Reg•Watch for more on the bill.

Yesterday, the Senate attached by a voice vote a drug importation amendment to the PDUFA reauthorization/FDA reform bill moving through the chamber. However, the amendment passed with its own amendment (called a second-degree amendment) which requires the Department of Health and Human Services to certify the safety and cost-effectiveness of all imported drugs.

The FDA does not have the resources to assure the safety of all domestic drugs, let alone imported ones. Therefore, the second-degree amendment renders the drug importation amendment impotent. Nonetheless, the second-degree amendment passed 49-40, with 33 misguided Republicans, 15 wayward Democrats, and Sen. Joe Lieberman voting in the affirmative. (Here's the roll call.)

Proponents of second-degree amendment raised safety concerns about drugs coming into the U.S. from Canada or the E.U. But this argument is specious. The drugs being imported are manufactured by American companies and are subject to strict safety tests in the exporting country.

It is unclear what this amendment will mean for the fate of the overall bill. President Bush has vowed to veto a bill containing a drug importation provision. However, since this provision is mere rhetoric, the bill may now be more palatable to the White House. A final vote on the Senate bill is expected this week.

Early yesterday, the Senate voted favorably (63-28) to end debate on the drug importation provision of the PDUFA reauthorization legislation. The rest of the day was sucked into a sort of legislative vacuum, and no further progress was made. A final vote on the amendment will occur early next week. A vote on the entire bill may also occur next week.

"Senate Likely to Back Drug Reimportation" [Washington Post]

OMB Watch recently reported on OSHA's utter failure to promulgate meaningful standards in the Bush administration. Critics frequently point to a court-ordered metal coatings standard as the only significant action the administration has taken in its six-plus years.

But even when non-significant (these are subjective terms) standards are considered, OSHA's performance is dismal. Some fine investigative work by the good people at The Pump Handle blog acquired documentation from OSHA's communication office indicating the agency has promulgated 22 standards. Still less than four per year, but perhaps a passable performance.

However, on further inspection, The Pump Handle determined at least half of these 22 standards to be fairly bogus. Check out their analysis here.

Both The New York Times' and The Washington Post's editorial boards have weighed in on the Senate's Prescription Drug User Fee Act (PDUFA) reauthorization.

The Times brings us back to the crux of the issue: FDA's power to require the drug industry to pay for drug approvals. While these so-called user fees are an significant source of revenue for FDA, The Times articulates the concerns of many who are following the issue:

This is a dangerous dependency for an agency that regulates such a critical part of the nation's health care system. It's as if the nuclear utilities paid for oversight by the Nuclear Regulatory Commission. The potential for abuse in such a chummy atmosphere is clearly there.

Nonetheless, the reauthorization contains other valuable provisions and has almost unstoppable momentum. That is, unless President Bush decides to veto it.

Which brings us to The Washington Post editorial. In today's paper, The Post puts on its protectionist cap, opposing a possible amendment to the lesgislation which would allow importation of cheap drugs from Canada and the EU (see Reg•Watch's coverage from yesterday).

The Post also defers to the White House on the issue:

Further, President Bush has threatened to veto the bill if it contains such language. For the sake of common sense, and to enhance the chances of urgently needed legislation, the Senate should reject the importation amendment before passing the bill.

In other words, "This is too important an issue to question Presidential authority." Isn't that the kind of logic The Post used in the run-up to the Iraq invasion?

The Senate is set to hold a cloture vote on the drug importation provision today. Stay tuned to Reg•Watch for more.

UPDATE:The Senate approved cloture 63-28, ending debate on the amendment.

Be sure to check out the latest issue of our biweekly newsletter, The Watcher. Regulatory policy articles this time:

OSHA's Lack of Standard Setting under Fire

White House Tightens Grip on Regulatory Power Grab

House Subcommittee Steps Up Oversight on Regulatory Changes

Yesterday, Reg•Watch blogged about the various amendments to the Senate PDUFA reauthorization bill. An additional provision has become the subject of political wrangling.

Sens. Byron Dorgan (D-ND), Olympia Snowe (R-ME) and Chuck Grassley (R-IA) support a provision which would allow importation of drugs from Canada and the European Union. Yesterday, OMB released a statement indicating the president would likely veto PDUFA reauthorization if it included such a provision.

The White House argues importation poses a safety concern: imported drugs are not subject to FDA approval. Even if we excuse the recent litany of FDA screw-ups (too many to list on this blog), the White House's concerns are misplaced. Americans deserve access to basic drugs from countries with excellent safety records. Importation would save consumers money and stoke competition in the American pharmaceutical market.

What's really startling is Bush's veto threat. PDUFA reauthorization is considered must-pass legislation. PDUFA expires in September and the funds it provides FDA are necessary for the agency to operate. Moreover, the bill currently carries other provisions which would strengthen FDA's ability to regulate. With its usual bravado and contempt for bipartisanship and good governance, the White House would be willing to derail the bill thereby hindering FDA's operations severely.

For now, it seems as though Senate Democrats are willing to get on board with the White House. Dorgan has indicated he will consider withholding the amendment if he is promised an opportunity to introduce it at a later time. Unfortunately, if the drug importation provision is not attached to the must-pass PDUFA reauthorization, it will face a much more difficult track in Congress.

Reg•Watch Update:

• Cloture vote on drug importation amendment
• Opinions on PDUFA Reauthorization

Senate leaders on food and drug regulation continue to wrangle over provisions of the reauthorization of the Prescription Drug User Fee Act (PDUFA). A Senate Committee reported PDUFA to the Senate floor two weeks ago.

Because PDUFA expires in September, and because the funds it provides FDA are necessary for the agency to operate, the reauthorization legislation is considered a must pass. That makes it a golden opportunity for Senators to attach all sorts of additional provisions.

The most contentious thus far has been a proposal to give FDA the authority to approve generic drugs. The pharmaceutical industry opposes such a provision (surprise!), and, according to the National Journal (subscription) has the support of Senate Majority Leader Harry Reid. A provision for generic drugs would likely offer consumers more generic drug choices and lower prices. Sens. Ted Kennedy, Hillary Clinton, and Chuck Schumer are pushing for a generics provision. What is Harry Reid's deal?

Other additions include a moratorium on direct-to-consumer advertising for risky drugs, the creation of a single food safety monitoring agency (currently the duties are split among several bodies including FDA and USDA) and increased pet food safety monitoring, all according to the National Journal.