FDALegislativeWatch

FDA's Labeling Rule Should Be Tweaked Firms Say. Dems Want It Squashed.

FDA appears to have a relatively smooth task ahead of itself as it works to finalize its proposed rule delineating when firms can change product labels without prior agency approval since the comments supporting the proposal contain few suggested changes.

Whether the rule would be implemented, however, remains in question, given the amount of congressional pressure on FDA to withdraw it. The administration appears committed to finalizing the proposal, but must race against the clock to finish because if it is issued late in the year, the next president may have the power to suspend it due to the 60-day latency period for most new rules.

CMS Reconsiders Data Collection Requirements for Oncologic PET Scans

CMS will consider a request to lift its registry-enrollment requirements for positron emission tomography scans for certain cancers, the agency said April 10.

Creators of the National Oncologic PET Registry, formed in 2006, say they have collected enough data to support unfettered Medicare coverage of PET to diagnose, stage and uncover recurrences of brain, ovarian, pancreatic, small cell lung, prostate and other cancers.

AIDS Drug Rebates Were "Largest Driver" of ADAP Budget Growth in 2007

Manufacturer rebates on AIDS drugs now account for 18 percent of the overall budget for AIDS Drug Assistance Programs, compared to 6 percent in the mid-1990s, according to the National ADAP Monitoring Project's annual report, released April 8.

Such rebates are an "increasingly critical component" of the budget for many ADAPs, the report says, and accounted for one-third or more of the budget for ADAPs in 11 states. They were the "largest driver" of ADAP budget growth in fiscal year 2007.

AstraZeneca In The "Transparency" Era: An Interview With CEO David Brennan

If you visit AstraZeneca's offices in Washington, D.C., your name has to be on a list. After you get your badge, you show it at the elevator bank to a guard, who, in a throwback to operators of yore, steps inside with you to unlock the keypad and send you on your way.

Once you reach the company's offices themselves, though, you step into a warm lobby full of light wood and see the broad glass doors of the conference room beyond.

The entrance ritual is fitting and rewarding, because it offers a visual analogy to the arguments put forth by AstraZeneca CEO David Brennan, who says that pharmaceutical companies must rigorously protect their intellectual property but also be open to more scrutiny by outside parties.

Potential Federal Drug Savings Could Propel Biosimilars Bill

The potential for biosimilars to lower Medicare and Medicaid drug spending could help catalyze support for a follow-on biologics bill this year, a Capitol Hill staffer predicted at the Food and Drug Law Institute's annual conference March 26.

Congress could use lower federal drug expenditures resulting from a biosimilars bill to offset higher spending elsewhere, explained David Schmickel, who currently is on detail from the National Institutes of Health to the Senate Health, Education, Labor and Pensions Committee's Republican staff.

Anxiety Over Prospects For Legislative 510(k) Reform Appears To Be Growing

FDA and industry are concerned Congress will revise the 510(k) process and defended the program and warned against statutory reforms during a panel discussion at the Food and Drug Law Institute annual meeting in Washington, D.C.

Heather Rosecrans, the acting head of the unit within FDA's Office of Device Evaluation that sets 510(k) and PMA policies, called the 510(k) process a "a well-oiled machine" and said during the March 26 session that there was no need for Congress to step in.

FDA Begins Review of E-Pedigree Options Just As California Delays Its Plan

With testimony that fewer than one in seven pharmaceutical manufacturers could be ready for California's planned implementation of electronic pedigree rules on Jan. 1, 2009, the State Board of Pharmacy decided to delay implementation for another two years.

The action comes just a few days after FDA requested public input on the status of e-pedigree technology and standards development. The agency is seeking the information as the first step toward implementing product "track and trace" provisions of the FDA Amendments Act.

FDA Commissioner Says Funding Imperils Agency Mission, Modernization

FDA's modernization efforts are essential for the agency to succeed as a regulatory organization in the future, but there will be no "quick fix," FDA Commissioner Andrew von Eschenbach said March 26 in an address to the Food and Drug Law Institute's annual conference.

Von Eschenbach offered perspectives on both the state of FDA and the opportunities and hurdles posed by the FDA Amendments Act. While von Eschenbach has spoken out before on challenges facing FDA, his address to FDLI was strikingly candid and wide-ranging.

Schering's Zetia Promotion to Physicians Draws Inquiry From Senator Kohl

Senate Aging Committee Chairman Herb Kohl, D-Wisc. requests that Schering-Plough provide information on a recent physician-aimed marketing campaign for Zetia (ezetimibe), in a March 13 letter to the firm.

With the inquiry, Kohl turns up the heat on congressional interest in marketing practices for Zetia and Vytorin (ezetimibe/simvastatin) in light of the negative ENHANCE results). The House Energy and Commerce Committee also has sent letters to Schering and Merck on the issue.

Reauthorized Bill Could Offer Bigger Grants To More Small MedTech Firms

The device industry and venture capital firms hope a House bill reauthorizing the Small Business Innovation and Research program will give more federal R&D funds to small firms regardless of their financial backing.

"One of the cornerstones of government investments in small medical technology companies has been the SBIR program," said Mark Leahey, executive director of the Medical Device Manufacturers Association (MDMA), at a March 13 House Small Business Committee hearing on the reauthorization bill.