Food safety

Congress will work quickly this week to try to pass a food-safety bill for a second time, after the version approved by the Senate was thrown out because of a technical error.
 
The Senate bill had passed 73-25. It creates fees, violating a constitutional requirement that tax bills must originate in the House of Representatives. This means opponents will have a second chance at holding it up before the lame-duck session expires.
 
Congress will also look to pay for a yearlong fix to the Medicare payment system after approving a monthlong patch earlier this week. Sens. Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) said they are committed to finding a yearlong solution to the sustainable growth rate (SGR) formula, which determines Medicare payments to physicians. Without the projected $17 billion “doc fix,” physicians face a 25 percent reduction in payments starting Jan. 1.
 
Nursing home advocates are still hoping the Senate will repeal the delay of a Medicare payment system for nursing homes. The House already approved it.
 
Also, the Senate is under pressure to quickly pass legislation providing healthcare for the first responders at the scene of the 9/11 attacks in New York. The House passed the $7.4 billion bill, 268-160, in September.
 
House committee chairmanship elections are expected Tuesday. One of the most contentious races is for the gavel of the Energy and Commerce panel, which has jurisdiction over health policy. Rep. Fred Upton (R-Mich.) is the favorite; the current ranking member, Rep. Joe Barton (R-Texas), needs a term-limit waiver. Reps. Cliff Stearns (R-Fla.) and John Shimkus (R-Ill.) are also running.
 
Off Capitol Hill, on Monday, the Center for American Progress will discuss the socioeconomic effects of the Hyde Amendment’s prohibition of Medicaid funding for most abortions. Panelists include the CEO of Black Women for Reproductive Justice and the director of the Washington chapter of the American Civil Liberties Union.
 
On Thursday, the American Constitution Society will host a panel of law and bioethics experts to discuss whether the Constitution protects the right of a competent, terminally ill individual to choose assistance in dying.
 
The Centers for Disease Control and Prevention’s National Influence Vaccination Week starts Monday, providing healthcare professionals an opportunity to promote flu vaccination before the typical winter spike in flu activity. Three strands of flu are expected this year, including last year’s dreaded H1N1 pandemic strain.

Top Republicans on the Energy and Commerce Committee wrote to the Food and Drug Administration on Friday questioning a new policy banning the agency's employees from owning family farms.

The FDA memo, dated Sept. 29, instructs employees to sell their farming interests within 60 days in order to comply with conflict-of-interest rules.

"We are concerned that the actions demanded by the September 29 memorandum may be unreasonable, if not draconian, both in substance and in form. We are not aware of any actual case or problem justifying the reinterpretation," writes ranking member Joe Barton (R-Texas) and oversight subcommittee ranking member Michael Burgess (R-Texas). "Thus, it is a mystery to us how these FDA employees who own family farms, many of whom have reported their farming to the agency through financial disclosures for 14 years, now suddenly stand to potentially harm 'public confidence in the impartiality or objectivity with which FDA programs are administered' or to otherwise raise serious conflict of interest concerns under the standards of ethical conduct for employees of the executive branch."

In their letter, the two Republicans request that the FDA answer the following questions:

• How did the reinterpretation of FDA’s employee conflict of interest rules, as reflected in the September 29 memorandum, come about? 

• What was the basis for FDA to reject measures such as recusal that are short of divestiture to address any ethics concerns?

• What was the reasoning behind the September 29 memorandum’s demand that the FDA employees' farm ownership interests be sold within 60 days?

• How many FDA employees stand to be affected by the memorandum’s demand that they divest from their farm ownership interests within 60 days? 

• Has FDA given any consideration to the financial or other harms that may be incurred by employees unable to carry out the demands of the September 29 memorandum within the 60-day period?

• Until what date will the enforcement of the reinterpretation of FDA’s conflict of interest rules governing FDA employees be held in abeyance? What procedures are in place to review and/or renew this enforcement suspension prior to arrival of that date? and 

• What steps has FDA taken to ensure that employees affected by the reinterpretation, and any future modifications, will be notified thereof in full, and within a reasonable period of time?

Senate Democrats say an error in the food-safety bill passed Tuesday can be resolved in time to send the legislation to President Obama by the end of the year.
 
Two senior leadership aides confirmed the bill the Senate approved, 73-25, inadvertently contained tax provisions that, under the Constitution, must originate in the House of Representatives. That means the bill must be passed a second time by the Senate, giving critics such as Sen. Tom Coburn (R-Okla.) another chance to block it.
 
Yet the aides said another vote can be successfully held before 2011.
 
"We are confident that we can work with our House colleagues to find a path forward and get this bill to the president before the end of the year," one of the aides said.

While the changes themselves might not be too complicated, the Senate will have a much tougher time passing the bill again. Coburn is expected to object to passage by unanimous consent, as he has in the past, and Senate Republican leaders say their caucus won't vote on any bills until the expiring tax cuts are dealt with.

House Majority Leader Steny Hoyer (D-Md.) indicated Wednesday the House was prepared to move on the Senate bill.

"While we think our bill was much better, we're prepared to pass a bill along the lines that they passed," he said. "Unfortunately, they passed a bill which is not consistent with the Constitution of the United States.

"It has to be a House bill, because it has revenues in it. ...That's a constitutional requirement. ....The Senate knows this rule, and should follow this rule. ...Nobody ought to be surprised by this rule."

Hoyer said he met Wednesday morning with Sen. Tom Harkin (D-Iowa), the sponsor of the Senate version, about the constitutionality question. 

"I'm hopeful that we will pass that back to the Senate in a corrected version. ... I presume they'll be able to pass it — it passed pretty handily in the Senate."

Hoyer said he's also spoken with the chief proponents of the bill — including Reps. John Dingell (D-Mich.), Rosa DeLauro (D-Conn.), Henry Waxman (D-Calif.) and Dennis Cardoza (D-Calif.) — who had been pushing for the stronger House version. The implication was that those lawmakers have agreed to accept something weaker, like the Senate bill.

— This post was updated at 1:46 p.m.

A food-safety bill that was expected to easily clear the House after passing the Senate on Tuesday now appears to be on life support, Roll Call reports. 

The reason: The Senate mistakenly incorporated tax provisions that are supposed to originate in the House, making it all but certain the lower chamber will send it back to the Senate to fix. 

While the changes themselves might not be too complicated, the Senate will have a much tougher time passing the bill a second time this lame-duck session as time is running out. Sen. Tom Coburn (R-Okla.) is expected to object to unanimous consent as he has in the past, and Senate Republican leaders say their caucus won't vote on any bills until the expiring tax cuts are dealt with.

The Food and Drug Administration (FDA) will face a number of challenging issues as it works to create a pathway to bring generic versions of biologics into the market, speakers said at a Brookings Institution panel Wednesday morning.

The healthcare reform law allows for the approval of so-called biosimilars after 12 years of patent exclusivity. However, critics have warned that the law provides the FDA with too much leeway to approve these drugs — including the flexibility to decide if clinical trials are even necessary.

Biologics are medications and other medical products created through the biological process instead of chemistry. Experts have warned that the biosimilar manufacturing processes can alter the drugs in ways that cannot be detected.

Mary Pendergast, president of a biotech consulting firm, said the 12-year approval process raises the question of whether a generic biologic will be consistent with the original drug.

"If you have a pioneer in year 12 that has a product different from the biologic that was tested for a biosimilar in year two or three, at year 12, are they going to be biosimilar or not?" she said.

The FDA is being asked to make "very tough scientific decisions" over whether one drug is biosimilar to another drug, Pendergast said, adding that she expects Congress will continue to battle the FDA over requirements for the biosimilar approval process.

"Members of Congress have already told the FDA what they think they should do, which may or may not be identical to law as written," Pendergast said. "The FDA will be under pressure from the innovator and biosmilar industries one way or another. This is very difficult to the FDA."

The author of the House’s food-safety bill has “remaining concerns” with the version passed Tuesday by the Senate, but said “we cannot let the perfect be the enemy of the good.”

“The Senate bill makes improvements to FDA’s existing authorities to ensure the safety of the American food supply just as the House bill does,” Rep. John Dingell (D-Mich.) said in a statement to The Hill. “I commend my colleagues for their hard work over the past year and four months. However, there are some remaining concerns with the final Senate legislation and I need to review the final product now that it has passed the Senate.

The Senate voted 73-25 for the bill, which calls for more frequent inspections at food-processing plants and gives the Food and Drug Administration broader authority in food-recall cases.

House Democrats united behind the Senate version of the childhood nutrition reauthorization Tuesday afternoon, promising to fix cuts that the Senate bill makes to food-stamp funding.

Democratic leaders said they will vote Wednesday on the $4.5 billion Senate version of the bill, which is partially paid for by ending food-stamp funding — provided by last year’s Recovery Act — in November 2013, five months earlier than scheduled. Democrats said they had “assurances” from the White House to work with Congress to restore the food-stamp funding.

Though Democrats came out against the food-stamp cuts, they made it clear the Senate bill, which is paid for and passed the Senate unanimously, is their best chance of passing the reauthorization.

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The House may pass the Senate version in order to get the legislation to the president's desk.

The Food and Drug Administration (FDA) has improved its working relationship with life sciences companies, but more than one-third of U.S. consumers have lost confidence in the agency over the past two years as the result of high-profile product recalls, according to new surveys from PricewaterhouseCoopers (PwC) and Biocom.

More than one-third (38 percent) of the 50 life-sciences companies surveyed said that the overall working relationship with the FDA has improved over the past two years, while 80 percent said the FDA is providing better guidance about its expectations.

However, the FDA has failed to keep up with advancing technology, the report said. Only 8 percent of drug makers and device makers said the agency is doing enough to advance personalized medicine.

Despite eroding consumer confidence in the FDA, the survey of 1,000 U.S. adults found that 93 percent are confident about the safety and effectiveness of medical devices approved for use in the United States. Still, 56 percent said they would be willing to use drugs and devices approved outside the country before they receive FDA approval.

Almost all (97 percent) said they consider the reputation of the company making the drug or device when deciding whether or not to use it.

Democratic lawmakers will call for swift passage of the child-nutrition reauthorization legislation in a conference call later this afternoon.

The House is expected to vote on the bill this week, and the Senate already unanimously approved a $4.5 billion version of the bill in August.

Speaker Nancy Pelosi (D-Calif.) and Reps. George Miller (D-Calif.), Rosa DeLauro (D-Conn.), Carolyn McCarthy (D-N.Y.), James McGovern (D-Mass.) and Sen. Blanche Lincoln (D-Ark.) will speak in support of the legislation.

The Senate bill, championed by Lincoln, expands eligibility for school meal programs; establishes nutrition standards for all foods sold in schools; and provides a 6-cent increase for each school lunch to help cafeterias serve healthier meals. The House has been considering a $8 billion version of the bill sponsored by Miller, chairman of the Education and Labor Committee.