Plan B: The Road Ahead

With at least 44,000 Plan B comments still under review at FDA, it is unclear when the agency will take its next step toward a decision on the proposed switch. In the meantime, those seeking OTC sale of EC are not keeping quiet on the issue. With lawsuits pending and pharmacy access to the drug increasing among individual states, there is plenty in store for Plan B in the coming year...

The proposed Rx-to-OTC switch of Barr Labs' Plan B emergency contraceptive likely will remain a prominent issue in 2006, despite FDA's delay in issuing a decision on the application.

Litigation that would compel an agency decision deadline, work by women's advocacy groups, and the growing trend of pharmacy access to the drug in individual states all are issues garnering media attention and keeping interest in the Plan B issue high.

Most stakeholders do not anticipate an FDA update on the rulemaking process in the near future. The agency announced in August an advance notice of proposed rulemaking to collect comment on whether a drug can be sold Rx and OTC simultaneously at the same dose and for the same indication (¹ (Also see "FDA “Unable” To Decide On Plan B, Seeks Comment On Dual-Status Drugs" - Pink Sheet, 29 Aug, 2005.), p. 4).

While the ANPR was widely interpreted as a delay tactic, those who advocate a switch are seeking other venues in which to increase awareness of the drug and further the debate about its OTC sale.

The Litigation Front

Litigation efforts would likely have the biggest and most immediate impact on Plan B if court rulings in two different lawsuits are issued in the coming year.

A district judge overseeing a lawsuit filed by the Center for Reproductive Rights against FDA is currently evaluating whether the case should be moved to appeals court.

CRR filed the lawsuit in January 2005 in New York district court, alleging that FDA's May 2004 "not approvable" letter to Barr constituted an "arbitrary and capricious" decision.

The suit asks the judge to compel an agency decision on the switch.

During oral arguments in December, Judge Edward Korman noted that if a drug manufacturer were to dispute an FDA decision, it would be required to do so in appeals court. The fact that the plaintiff is not a manufacturer leaves room for debate on the issue.

CRR filed a response Jan. 27 that the case should not be moved to the appeals court, and is now awaiting a decision by the judge.

During the December hearing, Judge Korman denied the government's request to dismiss the case and did "not necessarily accept" FDA's argument that CRR has no grounds for a lawsuit since it is not the manufacturer who filed the application.

It is possible that Barr does "not wish to launch a wholesale legal war" over Plan B, Korman stated.

"They may be concerned about getting on the wrong side [of] people at the FDA whom they may have to deal with in other instances where they're actually seeking approval of drugs."

"That might be an instance in where you could conceive of an argument... where the third party is 'hindered' from asserting his own rights."

Korman also stated that the agency's ANPR "has all the earmarks of an administrative agency filibuster."

"What you're talking about here is a fundamentally endless process which in no way will deal with the issue of sales of this drug to minors," Korman said.

Commenting on the amount of time it will take for FDA to evaluate the 44,000 comments it received on the rulemaking, Korman stated: "there aren't tens of thousands of reasons" that stakeholders would support or oppose the rulemaking.

"There are probably two or three reasons that tens of thousands of people have," he said.

An amended complaint filed Jan. 31 by CRR provides new factual and legal allegations, including reference to a November report by the Government Accountability Office which found that FDA's review of Barr's application was "unusual" (² (Also see "FDA Disagrees With GAO’s “Unusual” Findings Regarding Plan B Decision" - Pink Sheet, 21 Nov, 2005.), p. 4).

A separate, pending legal action refers to the GAO report as evidence of FDA's violation of the Administrative Procedures Act.

Wisconsin Attorney General Peg Lautenschlager is expected to file a lawsuit against FDA claiming that the agency's "politically motivated actions" are negatively affecting state residents.

Lautenschlager received permission in December from Gov. Jim Doyle (D) to file the suit. She is asking the Department of Health & Family Services to investigate the impact that limited availability of Plan B is having on women's health and state resources.

Seeking HELP

Women's advocacy groups are taking matters into their own hands, and are placing their focus on Sen. Mike Enzi (R-Wyo.), who chairs the Health, Education, Labor & Pensions Committee. A coalition of groups will meet in the next few weeks to discuss strategies to lobby the senator to hold hearings on Plan B.

Sens. Hillary Clinton (D-N.Y.) and Patty Murray (D-Wash.) called on Enzi to hold hearings upon learning of the ANPR in August. Enzi's office says that Plan B hearings are not on the docket for the next month.

In addition to pushing for hearings, work by advocacy groups to provide education on the drug's availability continues to make headlines.

Publicity, Publicity, Publicity

Perhaps the best strategy going forward for those advocating a switch is to actively work to keep Plan B public awareness high.

In an effort to provide education, the Reproductive Health Technologies Project launched the "Susan Wood: FDA Hero Speaking Tour" on Jan. 26.

Wood resigned from FDA's Office of Women's Health in protest following the announcement of the ANPR (³ (Also see "FDAer Resigns Over Plan B; Senators Seek Results Of GAO Investigation" - Pink Sheet, 5 Sep, 2005.), p. 3).

Wood has 24 speaking engagements scheduled through the end of April at universities and professional associations in conjunction with advocacy groups. She was honored at NARAL's Roe vs. Wade anniversary dinner Jan. 31 in Washington, D.C. for her actions.

Wood's message is that with so much money spent annually on FDA-approved products, it is vital for the public to be able to trust the agency, RHTP noted.

She also has expressed concerns that the politics surrounding the Plan B switch may affect other health issues if applications are filed in the future for cervical cancer or HIV vaccines.

The continued debate over pharmacists who refuse to dispense Plan B for moral or religious reasons also is met with considerable media attention.

Three Massachusetts women who could not have their EC prescriptions filled at Wal-Mart filed a suit against the company Feb. 2 in Suffolk County Superior Court.

The complaint, filed by the law firm Broday, Hardoon, Perkins & Kesten, is based on a state law that pharmacies must stock all "commonly prescribed" medications, and seeks an injunction compelling Wal-Mart to stock EC.

Pharmacists opposed to filling Plan B prescriptions are fighting back with lawsuits of their own.

The American Center for Law & Justice filed a lawsuit Jan. 27 against Walgreens on behalf of four Illinois pharmacists who were fired by the retailer.

The same four pharmacists previously filed suit against the state's Department of Professional Regulation in December. The action followed state legislation requiring pharmacists to either fill prescriptions for Plan B or refer patients to another professional.

Press coverage surrounding the Plan B switch has had a positive effect on the drug's revenues. In May 2004, Barr CEO Bruce Downey said that prescriptions for the drug had doubled in a one-year period as a result of publicity.

The Plan B debate is also bringing general discussions about Rx-to-OTC switch to the fore.

The American Pharmacists Association named Rx-to-OTC switch as one of "Pharmacy's Top 10 Stories of 2005," due to the extensive news coverage of high-profile switches such as EC, statins and GlaxoSmithKline's weight-loss drug Xenical .

Step By Step, State By State

Some women's groups have said that until FDA signals whether or not it will proceed with a rulemaking, increasing pharmacy access to the drug is the next best option.

The National Women's Law Center is working with pharmacy boards in some states to help determine what their policies on pharmacy access should be.

Currently there are eight states with "collaborative practice" agreements that allow pharmacists to write a prescription for Plan B. Massachusetts and New Hampshire joined the roster in 2005; Alaska, California, Hawaii, Maine, New Mexico and Washington have provided access for some time.

Legislation was passed by New York's House and Senate in 2005, but failed to take hold after it was vetoed by Gov. George Pataki (R).

One positive outcome of the Plan B debate is that the issue is now on the radar screen of the state chapters of some national organizations, said Kirsten Moore, President and CEO of the Reproductive Health Technologies Project.

For example, a bill in South Dakota that would make EC available to women during visits to the emergency room recently passed its first hurdle in the state legislature, Moore said. The accomplishment is noteworthy, she added, because the state previously had not made any efforts to expand EC access.

Other state initiatives include New York City Mayor Michael Bloomberg's April 2005 "Healthy Women/Healthy Babies Initiative."

Under the $3 mil. program, the state's Department of Health & Mental Hygiene will spend $1 mil. in partnership with community and healthcare organizations to increase awareness and access to EC. The Department also will use the resources to educate pharmacies about EC and encourage them to keep it in stock.

Oakland, Calif.-based Pharmacy Access Partnership is conducting research on EC use in the community. The group recently was awarded a grant from the Institute for Reproductive Health Access to analyze Los Angeles County as a case study for EC change.

"Los Angeles offers a unique opportunity for this project for several key reasons, including its widely diverse and large urban population, the vast number of pharmacies," the group said.

Pharmacy Access also will use the grant "to support the formation of a statewide network of women's health advocates, healthcare providers and pharmacists working toward improved EC pharmacy access."

In January, the group partnered with the Pacific Institute for Women's Health to conduct the last of six statewide focus groups gauging female Latina and African-American adolescents' views on EC pharmacy access.

Results of the focus groups will be used to "develop a state-based social marketing campaign to increase teens' awareness of EC pharmacy access."

Barr's Plan C?

Barr also has been active in its efforts to advance pharmacy sale of Plan B.

The firm is "very committed to trying to expand pharmacy access" and has a "very active" government group, according to Carole Ben-Maimon, MD, president and COO of the Barr subsidiary Duramed Research.

According to Barr VP-Investor Relations Carol Cox, the company is active in states where pharmacy access has been proposed, but does not proactively lobby for introduction of state legislation on the matter.

For example, the firm was involved in pharmacy access efforts in New York, New Hampshire and Massachusetts in 2005, but "only after the ball was rolling" in those states, Cox said.

Barr's involvement largely involves speaking to state legislators and providing information and answers about the drug when requested. The firm also works with state pharmacy boards about legal requirements for collaborative practice agreements.

Barr also announced in September that it would test a point-of-purchase program in drugstores, with signs in the feminine hygiene aisle directing consumers to ask their pharmacist about Plan B (⁴ (Also see "Plan B Pharmacy Access Sales Growth Offers Silver Lining To FDA Delay – Barr" - Pink Sheet, 26 Sep, 2005.), p. 3).

While the firm is increasing awareness of the drug, Barr currently is not planning new advertising initiatives for Plan B, Cox said. The drug's annual sales of $20 mil.-$25 mil. are relatively small compared to the firm's overall $1 bil. in sales each year, she noted.

One of the company's next steps is to conduct a survey of women and their understanding of how to use Plan B. Barr's goal is to conduct the survey in all 50 states and perhaps gain insight as to the difference in understanding of the drug by women in states that offer pharmacy access and those that do not.

A Third Class For One And All?

The American Pharmacists Association hopes that pharmacy access to Plan B will one day exist nationwide.

In comments on FDA's Plan B rulemaking, the trade association emphasizes that "there may be drug products in which the standard two class system is not sufficient."

There are certain drugs which do not require the assistance of a learned intermediary, but for which patients would benefit from access to a health professional's services, APhA states. "Such access may not always be available with 'full' OTC status."

If FDA chooses to amend the Food, Drug & Cosmetic Act through the rulemaking, "the agency should consider creating additional classes of drugs," the submission states.

"Dual-status products would work well within the Pharmacy Care OTC concept," which does not require, but strongly suggests, that a pharmacist be consulted prior to sale.

The Post-Plan B Switch Era

Even if a decision on Plan B's OTC sale is not reached in 2006, the debate surrounding the drug will likely extend to discussions about other proposed switches.

Answering the questions raised by FDA in the ANPR could "establish pathways that could make many more products available" over-the-counter, former Commissioner Lester Crawford stated in the August announcement.

The link is especially relevant as FDA increasingly sees switch proposals of drugs for which behavior and education are important components of proper use.

In the last year, Merck's proposed switch of Mevacor (lovastatin) and GSK's Xenical have demonstrated such a transition.

For example, the proposal to limit availability of OTC Xenical to those 18 and older has sparked discussion about safety concerns for teenagers hoping to obtain the drug.

- Bridget Behling