The Supreme Court is set to hear a patent infringement case next month that centers on the use of soybean seeds but could have far-reaching impacts on biotechnology, such as regenerative medicine treatments with multiple generations. A Biotechnology Industry Organization attorney said the case goes beyond whether reproducing these replicable products is tantamount to patent infringement, and addresses whether the patent owner has any control over the use of its product after it is reproduced.1171 words

FDA's recent approval of an anthrax antitoxin -- the first new chemical entity to be approved under a rule allowing companies to test for efficacy using animal models -- shows the agency is making progress in its efforts to improve regulatory science, and could provide a pathway for other companies developing medical countermeasures, sources said. However, one source cautioned that other products, such as vaccines, could be more difficult to assess using these models allowed by the animal rule.1098 words

The Minnesota Medical Device Alliance has petitioned FDA to hold off finalizing guidance on evaluating substantial equivalence for 510(k) devices until the agency addresses a laundry list of regulatory issues identified by the alliance related to least burdensome standards, the de novo pathway and reviewer training. Among other things, the group wants FDA to revert back to policies outlined in pre-2009 guidance documents on several key issues.769 words

FDA on Thursday took the unusual step of pushing a unique dosage level for woman as it called on sponsors of sleeping drugs to halve the recommended dosage for women of drugs containing the active ingredient zolpidem, a step the agency took while also saying it will require sponsors of new sleep drugs to perform driving simulation studies and encourage sponsors of already-marketed sleep drugs to also perform these studies. Requiring different dosing recommendations for women and men based on how they eliminate a drug is unusual, said Ellis Unger, director of the Office of Drug Evaluation I in FDA's drug center, in response to a question from FDA Week, while adding that it is "quite unusual" for women to metabolize a drug more slowly to the point where it would require different dosing, as is the case with zolpidem.603 words

Vertex Pharmaceuticals stepped forward this week and said it received FDA's first two breakthrough drug designations, and will use the designations to expand uses for its landmark cystic fibrosis drug Kalydeco, ending widespread speculation about which company received the initial designations enacted by the FDA Safety and Innovation Act. The drug, although approved before the new program existed, was seen as an example of the type of product that could be a breakthrough candidate, according to a stakeholder who backed the program's inclusion in FDASIA.804 words

FDA has received 15 requests for breakthrough drug designations, three of which were denied, the agency said releasing updated numbers for the new pathway this week. The numbers mark a notable uptick since mid-December when FDA drug center officials said they received seven designation requests and denied one.171 words

FDA issued long-awaited draft guidance on abuse deterrent formulations for opioids Wednesday (Jan. 9) laying out premarket and postmarket study requirements that would allow innovator companies to add abuse deterrent claims to their labels, but the agency said it still needs more data before it can determine whether the new formulations deter drug abuse. The agency also put off deciding whether to require that generic painkillers be abuse deterrent -- a response that drew criticism from an advocacy group -- but said abuse-deterrent product claims should make these products more attractive to physicians and payors.1070 words

FDA marked the second anniversary of the Food Safety Modernization Act Friday (Jan. 4) by releasing long-delayed proposed regulations on preventive controls and produce safety. Under the landmark food safety law, FDA was supposed to release a final preventive control rule last summer and the deadline for a produce proposal passed a year ago. FDA said other FSMA rules on the foreign supplier verification program and the third-party accreditation standards for food audits will soon follow.481 words

FDA's proposed produce safety standards outline requirements for workers, water, soil, animals, facilities and sprouts, and lay the groundwork for a key component of the new food safety system mandated under the landmark law signed two years ago. One industry stakeholder said FDA already signaled key components of the regulation, such as the focus on these areas of risk and some exemptions, therefore producers are prepared to tackle the new requirements.764 words

Exemptions in FDA's newly proposed rule on hazard analysis and preventive controls for human food hint at the agency's flexibility in tackling one of the cornerstones of a new food safety system, said one industry attorney. The rule will require manufacturers have a written food safety plan and establish preventive controls for hazards likely to occur in facilities, but separate standards for animal feed remain under review at the White House Office of Management and Budget, although FDA officials expect their release soon.1001 words

The Supreme Court scheduled oral arguments in two highly watched drug preemption and patent settlement cases for March. The high court will hear Mutual Pharmaceutical Co. v Bartlett, a generic drug preemption case, March 19, followed by oral arguments in a case examining the legality of patent settlements, FTC v. Watson Pharmaceuticals, et al., March 25.196 words

A statutory mandate for FDA to begin enforcing testing and labeling requirements for sunscreen went into effect last month, but a cosmetics industry group said companies making small cosmetic products like lipsticks are still struggling to comply with labeling changes and suggested FDA make exceptions for those products. An environmental advocate, however, called the regulations weak and questioned whether further legislative action would be needed for FDA to make other delayed decisions on sunscreen, such as whether to cap SPF claims at 50.679 words

Food and Water Watch Thursday (Jan. 10) urged the Obama administration to release a proposed preventive controls rule on animal feed and another outlining the foreign supplier verification program, which would hold importers accountable for the safety of imported pet treats tied to a rash of foodborne illnesses. The call for action came after Nestle Purina and Milo's Kitchen, a Del Monte company, Wednesday (Jan. 9) recalled products because of undisclosed antibiotic residues.272 words

A top Generic Pharmaceutical Association official is leaving to join Watson Pharmaceuticals, the company announced on Wednesday (Jan. 9). James Fenton has been named Watson's vice president of U.S. government affairs. He was previously the senior vice president of government affairs for GPhA and directed industry efforts on the Generic Drug User Fee Act.144 words

Texas lawmakers are raising concerns that companies with pending investigational new drug applications for new medical gases could be included in an FDA list of certified gases which in turn would effectively allow other companies to also manufacture and use their gas. But FDA responded to the lawmakers that it will not limit its ability to put medical gases under the new certification requirements mandated by the FDA Safety and Innovation Act, despite their request that the agency explicitly exempt gases with pending INDs.696 words

Massachusetts Gov. Deval Patrick (D) on Jan. 4 unveiled a legislative proposal and additional measures to beef up his state's oversight of pharmacy compounding by enhancing inspections and reforming the state board of pharmacy -- a proposal that builds on recommendations released the same day by Massachusetts' newly formed pharmacy compounding commission. Rep. Ed Markey (D-MA) said the proposal is a "robust state complement" to a bill he plans to re-introduce in the new Congress to beef up federal oversight of large-scale compounding pharmacies.805 words

Republican Sens. Lamar Alexander (TN) and Susan Collins (ME) will take over as the ranking members of two key Senate health committees, according to a list of Senate GOP committee leadership assignments obtained by Inside Health Policy.167 words

Nearly four out of 10 physicians surveyed said they "sometimes or often" prescribe brand-name drugs over generics because patients ask them to, and drug company relationships with physicians exacerbate the trend, according to a study published Monday (Jan. 7) by JAMA Internal Medicine. Generic drugmakers said the study shows there are savings to be achieved by turning to generics, while Pharmaceutical Research and Manufacturers of America countered that physician prescribing decisions are influenced by a slew of factors such as formularies, clinical guidelines and continuing education.769 words

Medical specialty societies that have been urging the administration and Congress to allow provider participation in qualified clinical data registries to count towards the Physician Quality Reporting System (PQRS) requirements are thrilled that their proposal made it into the "fiscal cliff" deal. Inside Health Policy has also learned that CMS intends to examine ways that clinical registries could be used to satisfy meaningful use requirements, and plans to seek public input on the concept sometime in the next few weeks as part of a request for comments on the development of criteria for a "qualified" registries.834 words

Consumer advocates met with White House officials Dec. 27 to urge them to quickly review the long-overdue physician-payment disclosure regulation and reject several revisions sought by the American Medical Association, according to consumer representatives who attended the meeting. CMS officials last year said they hoped to release the regulation by the end of 2012, and other stakeholders on Thursday (Jan. 10) sent their own letter urging the administration to move forward on the long-delayed rule.775 words