FDA contends that a GOP appropriations plan to slash the agency's budget by 21 percent below the White House's request, if enacted, would thwart the agency's ability to implement healthcare reform's biosimilars pathway, stop importation of illegal products, speed review of generic drugs and invest in medical countermeasures, according to leaked FDA documents, although an FDA official could not confirm the documents' veracity as of press time. The agency argues that the GOP-backed cuts also would both harm the economy and reduce protection of military personnel, two issues that many Republicans have traditionally attempted to improve.

FDA is raising concerns about a GOP appropriations proposal that would mandate the agency base its activities on "hard science," arguing that the measure would hinder FDA efforts in several key areas, including drug safety, blood safety, tobacco oversight, prevention of lead contamination in candy, and steps to address Bovine Spongiform Encephalopathy (BSE), according to documents obtained by FDA Week and sent by the agency to Capitol Hill.

Some industry stakeholders are questioning FDA's authority to request and review food facilities' safety and manufacturing records -- including preventive control plans -- outside of an inspection because remote record access was removed from the food safety law during the legislative process, as the agency weighs whether to mandate submissions of these documents. While remote records access is welcomed by some in industry as a measure to expedite inspections, many stakeholders have concerns with proprietary information reaching the public domain and about potentially misleading conclusions if preventive control plans are reviewed outside of a manufacturing facility.

A key congressional orphan product advocate is planning to introduce legislation soon that would encourage development of therapies for rare diseases where the new medicines lack patent protections, dubbing these drugs "dormant therapies," with his bill also promoting the production of co-developed diagnostics and therapeutics. A draft version of the bill, obtained by FDA Week, was developed by the National Health Council, and a congressional aide said bill language is now being reviewed.

The pharmaceutical industry will urge Congress to avoid amendments to the 2012 reauthorization of prescription drug user fees and cleanly pass the agreement reached with FDA, even though a large swath of other stakeholders intend to add their pet projects to the user fee package. John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said his group would not lobby to add new provisions to the fifth iteration of the Prescription Drug User Fee Act and Congress should instead pass the agreement without incorporating tangential measures.

FDA projects that implementation of the food safety law would be "significantly delayed" if the GOP-backed agency fiscal 2012 appropriations plan clears Congress, saying that import oversight, inspections and training will be hurt the most, according to leaked FDA documents.

Rep. Michael Burgess (R-TX) will question the White House regulations czar on how the administration intends to reform FDA's review of comments submitted on regulations following examples where some experts' comments were allegedly ignored, according to a Capitol Hill aide.

A major medical device industry trade association proposes that government agencies be required to develop an "industry impact statement" when they draft significant new regulations, with the group floating the proposal as part of a six-pronged competitiveness agenda that also recommends reforming FDA's device approval process and establishing a White House medical innovation office. The competitiveness plan, unveiled Monday (June 6) at an event with the top Republican on the Energy and Commerce Committee, emerges after House Medical Technology Caucus co-chair Erik Paulsen (R-MN) said he is working on legislation to ensure device approval regulations do not hinder industry innovation.

Food safety and consumer advocates are urging FDA to fully ban arsenic-containing compounds in animal drugs -- as is the case in Europe -- after Pfizer said it would remove a widely-used arsenic-containing animal drug from the market as a result of new FDA data.

FDA has increased surveillance of cucumbers, fresh tomatoes and lettuce from Spain and Germany as a result of the massive drug resistant Escherichia coli outbreak in Europe, agency officials said Friday (June 3), as lawmakers begin probing whether the United States is vulnerable to a similar pandemic. The agency established import controls as a safety precaution, the officials said, but they emphasized that the outbreak has not affected U.S. produce.

Food safety advocates are petitioning FDA not to make a final determination on whether to approve genetically engineered salmon, the first GE animal food product evaluated for human consumption, until the agency has conducted a comprehensive environmental impact statement, as FDA has not outlined the specific way it will take into account environmental considerations. The advocates also call for FDA to alter its product review framework to allow approval only if the product is deemed safe for the environment.

New findings published late last month by FDA researchers on concentrations of the chemical bisphenol A in canned food products have reignited calls by consumer advocates for FDA to ban the substance from all food containers and revise safety limits due to the high levels found, while an industry attorney asserts that the findings of significant variability in amounts of the compound could show that alternative packaging procedures may reduce chemical levels.

FDA dodged specifically defining nanotechnology in a new draft guidance on the materials released Thursday (June 9), instead opting to outline criteria it will use when evaluating this emerging technology, which is being increasingly used throughout FDA-regulated industries.

Sen. Sherrod Brown (D-OH) is criticizing another pharmaceutical company for its pricing decisions, saying in a letter to CMS that the trend, which recently drew interest with the price hike of a pre-term labor injection, appears to be a new model for drug companies. On Monday (June 6), Brown sent letters to CMS and URL Pharma, which manufactures the gout medication Colcrys, questioning the drug's price increase after FDA approved the medication that was previously available in an unapproved form, a move that the company contends brought a safer product to market.

FDA's approval of a host of generic breast cancer treatments Monday (June 3) as the remaining patent of the brand-name reference product expired clearly demonstrates how drug firms are delaying access to lower cost medicines through agreements that could include stipulations outlining when products can enter the market and whether the innovator firm can develop its own generic product, known as authorized generics, sources said.

Generic manufacturers are advocating for the high court to weigh in on a recent circuit court decision that lowered the bar for proving that patentees have lied to or misled the Patent and Trademark Office, citing the decision's inconsistency with Supreme Court precedent. The Generic Pharmaceutical Association brought up the issue, known as the doctrine of inequitable conduct, during the patent reform debate and expressed disappointment with the decision, which was lauded by biotech innovator firms.

A congressional proposal to revamp the HIV/AIDS drug development process by stripping away patents and exclusivity periods and instead create a prize fund that would provide lump-sum monetary payments to pharmaceutical firms upon approval could gain some significant attention and possibly even draw some drug manufacturers' support, even though a larger plan to strike these intellectual property and marketing rights for all pharmaceuticals is unlikely to move, sources said.

FDA's drug center is elevating its compliance office into a more prominent role and creating a sub-office dedicated exclusively to globalization and the supply chain in light of challenges ensuring the safety of products manufactured abroad, although the plan garnered only tepid support, and even resistance, from some industry stakeholders who said the reorganization might not be effective, and possibly hinder coordination.

The Supreme Court ruled Monday (June 6) that an agreement between Stanford University and its researcher did not prevent that academic from shifting the ownership of an invention developed using federal dollars to a third party, in this case Cetus Corporation, which was later acquired by biotechnology firm Roche. In response to the decision, the biotechnology industry and academic institutions said they would collaborate to ensure that technology transfer continues, even though the two groups backed different parties in the case.

House lawmakers are pushing legislation to mandate prescriber training, which is voluntarily required in FDA Risk Evaluation and Mitigation Strategies programs, as part of the Drug Enforcement Agency's registration database for controlled substances. As part of a broader administration effort to target prescription drug abuse, FDA is implementing a class-wide REMS for long acting and extended release opioids and is pushing for its prescriber training mandates to be incorporated in the database.

Consumer advocates are pushing for FDA to suspend food firms' registrations, thereby shutting them down, if the companies' products are forcibly removed from the market by the agency through its new mandatory recall authority, which was provided by the food safety law signed earlier this year. Industry stakeholders, though, are concerned about the economic impact of registration suspension, with one official saying that FDA should employ a process to rapidly reinstate companies.

A Customs and Border Protection program could serve as a template or provide guidance on pitfalls for defining firm qualifications and the benefits to companies for an expedited voluntary importer program established through the food safety law that enables more rapid access to the U.S. market, stakeholders said. The definitions and benefits should be more clearly outlined in the new program, which has raised questions among industry stakeholders about the perks of participating and consequences of not taking part.

The previous issue of FDA Week incorrectly stated that Marcie Bough is the director of federal regulatory affairs at the American Pharmacists Association. She is the group's senior director of government affairs. We regret the error.