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Plan B is a popular version of the “morning-after pill,” which can substantially reduce the chance of pregnancy if a woman takes it within 72 hours after having unprotected sex. The drug is currently available only by prescription in virtually every state, including Virginia. But in mid-December, an advisory committee to the Food and Drug Administration recommended that Plan B was safe enough for sale over the counter.

The news media jumped all over the announcement, giving the appearance to the casual headline reader or CNN viewer that the drug would be available on the shelf in Kroger in short order. In reality, however, the advisory committee, as its name suggests, was offering only advice. The FDA has the power to reject the recommendation. And with anti-abortion groups lined up in opposition of the morning-after pill’s approval as an over-the-counter drug, the final decision is anybody’s guess.

C-VILLE Weekly sat down with one local resident who can make an unusually educated guess on FDA decisions, Richard Merrill, a UVA law professor and former chief counsel to the FDA. Merrill’s take is that the morning-after pill still faces an uphill battle before it goes over the counter. He also says FDA chief Mark McClellan will likely be shoved in two directions, with his scientific advisors pushing for approval and his bosses in the White House seeking to appease the anti-abortion foes of the drug.—Paul Fain

Paul Fain: What factors influence an FDA decision to switch a drug from prescription only to over the counter?

Richard Merrill: The FDA would expect the manufacturer to be able to supply either clinical trial data or historical information that suggests that the incidence of adverse reactions or side effects associated with the drug were very low. That’s probably the most important thing.

Were you surprised that the FDA panel so overwhelmingly recommended that the morning-after pill be sold over the counter?

Given the controversy that surrounds this product, I guess I’m a little surprised that it was that decisive. But I would’ve been surprised if it had gone the other way, because these people, by and large, ask questions about “Can it be safely and effectively used by reasonably intelligent laypeople?” It seems to me the case for that is pretty strong. If they’d been asked other questions that had to do with the—you might say—the social desirability of having it available, you might’ve expected a wider, and more sharply divided panel.

Will the final decision be a tough one for the FDA?

I think it will be a difficult decision. At least if the press coverage of the advisory committee meetings is to be believed, not only was the vote, as you put it, quite overwhelmingly in favor of approval, but the tenor of the discussions among the committee members and the questions raised and debated and the arguments heard by members of the public would suggest that there is a strong, but not unanimous, consensus in favor of the switch [to over-the-counter status] at least on medical and scientific grounds. On the other hand, I suspect that there are pressures within the Bush administration to go the other way, and that makes it particularly difficult, I think, and sensitive for Commissioner McClellan. I’m sure that Karl Rove sees no advantage to Bush in the approval.

Could the FDA Commissioner approve the drug despite possible White House pressure?

As a legal matter, there’s no question that he has the latitude to do that. And indeed one could argue that a decision of this sort is a decision that is supposed to be based on the scientific merits and it is a decision that, by law, the Commissioner rather than anybody in the White House, is entitled to make … [President Bush] can fire him, but he can’t make the decision for him.

Why have anti-abortion groups, who are fighting the over-the-counter approval of the drug, kept the abortion argument quiet during the debate?

They pretty clearly made a decision, I think, that at least so far as the public debate that’s going to go forward, they’re going to treat it within the parameters that FDA usually operates, and not going to raise the stakes or change the discourse. That doesn’t mean, though, that there will not be pressures that reflect that very view, even if it’s not articulated, that are being brought to bear on McClellan. In some sense it makes it easier, they might think, for McClellan to disagree with the [advisory] committee. McClellan cannot issue a press release that says, “I’m not going to do it because in my view this kills babies.” He’s going to have say: “There’s an unanswered question about the safety of this product, about the extent to which young women are going to avoid getting medical counseling.”

What’s your prediction about how the FDA Commissioner will find?

One could write a decision rejecting [approval] for now, and that’s how it might come out: “There’s no ‘never,’ but there are some questions that need some further exploration, further research.” And I would think that that outcome is about as probable as approval, before the election. And it’s always possible that they’ll sit on it.

A walk in the park
Getting to know the nine acres of McIntire Park that will someday become a road

On a recent Wednesday afternoon, a golfer placed his ball on the fourth tee in McIntire Park, beside a babbling Meadow Creek. With a whoosh of his club and a soft ping, he sent the ball arching toward a red flag fluttering at the hole. The ball landed, plop, and the player hitched a bag of clubs over his shoulder and walked along a strip of land that will, someday, become Charlottesville’s portion of the Meadowcreek Parkway.

When the road is finally built, it will mark the conclusion of a decades-long battle between Charlottesville and Albemarle County. Until then, however, the S-shaped strip of land—curving from Melbourne Road near Charlottesville High School, through the park lowlands to the Vietnam Memorial at the intersection of Route 250 and McIntire Road—symbolizes how troublesome it can be for two separate jurisdictions to solve transportation problems.

To hike the land south from Melbourne Road, you first have to get around a 10′ fence that’s adorned with a sign prohibiting any dumping, even leaves, “due to environmental concerns.” An asphalt driveway overgrown with crabgrass leads down to the thorn bushes along the banks of Meadow Creek, the City’s most polluted waterway. The occasionally pretty brook absorbs most of Charlottesville’s run-off, and here in this no-man’s land between Melbourne and McIntire Park some sections of the creek glisten with a pink, oily film.

Across the creek and beyond the trees, the Parkway will swoop through the lowlands of McIntire Park. In 1926 Paul Goodloe McIntire, who had returned to his native Charlottesville after making a fortune on the New York Stock Exchange, donated to the City the land that would become McIntire Park.

Once this becomes a stretch of the Parkway, southbound drivers will see a steep hill to their right, with oak branches spreading against the sky.

For now, though, this strip of parkland belongs to the golfers and, on snowy days, a more daring breed of sled rider. While the Parkway project will pave over about nine acres of land, landscape architect Will Rieley, who is designing the City’s portion of the Parkway, estimates that about 19 acres of McIntire “will be altered significantly” when the road is finished.

Because the road will change land originally designated for everyone’s enjoyment, Virginia’s constitution protects the intent of donors by requiring local governing bodies to secure a four-fifths majority before paving public parkland.

The few acres of grass, trees and stray beer cans are the center of a conflict so intense it has caused Charlottesville’s City Council to turn on itself. One group of Councilors (Meredith Richards, Blake Caravati and Rob Schilling) hopes to accelerate construction of the Parkway by granting the land outright to the Virginia Department of Transportation against the opposition of Councilors Kevin Lynch and Maurice Cox. Both sides have rattled the saber of litigation.

Backdoor maneuvers by both the pro- and anti-Parkway factions have produced unusually intense feelings of mistrust inside Council. The obvious rancor on display at recent meetings reportedly holds off the dais, too, according to sources in the City. The two sides apparently aren’t speaking, a potential concern for those who have matters other than transportation to bring before the Council.

Given the will of the State and County to see the Parkway built, it seems like this S-shaped strip of land, a mere dot in the City’s 10 square miles, will be paved eventually. The question, then, is whether it will happen with the blessing of a cooperative Council working in the City’s best interests—all of them.—John Borgmeyer

Home movies
After a surprising success, an indie film producer wants to set up shop here

Barry Sisson was nervous when he arrived at the Sundance Film Festival in Park City, Utah, last January. The first screening of every movie had already been sold out, except for one, the one he cared about: an under-the-radar character study called The Station Agent that had only been edited the night before and flown to Sundance that morning. Sisson describes himself as “an active investor” in the film, a role the film’s producer, an old friend, drew him into. Not only that, but Sisson was on set during its three-week filming process, immersing himself in the world of indie filmmaking. At Sundance he stood among the empty seats and wondered what he had gotten himself into.

In true movie-magic fashion, the story has a happy ending. The partial crowd loved the film, and word of mouth spread so rapidly that before the festival was over, not only did The Station Agent win the Audience Award for dramatic film, but Miramax studio head Harvey Weinstein flew out for a private screening. By 6:30 the next morning, Miramax and the film’s producers had a deal. The ensuing accolades and wide distribution launched this low-budget indie into the national spotlight (it’s been running for several weeks at Vinegar Hill, an indication of its draw nationwide), and Sisson reassured himself that he had made the right decision after all.

The Station Agent was Sisson’s first movie investment, but he’s determined it won’t be his last. With this major success behind him, he’s diving into the movie business even deeper with the creation of a production company here in Charlottesville, where Sisson lives with his daughter, Bari, and wife, Terre, owner of a local tour company.

After 25 years as a businessman (electronic security), Sisson speaks of films in terms of quarters and business plans, asserting that good independent films can be profitable, too. He plans to produce films for less than $1 million apiece. By movie industry standards that’s a drop in the bucket—less than some films spend on wardrobe and makeup.

Currently he is shopping for scripts while awaiting the release of Charlie’s Party, the second film he invested in, which was test-screened in Charlottesville in December. Once the groundwork is laid for the new production company—sometime this spring, he says—his assistant Marc Lieberman (a UVA grad who has spent the past three years working on films in Los Angeles) will set up an office in New York to establish ties between the indie film community and Charlottesville.

But why Charlottesville? “A whole lot of the process can be done anywhere, so why not base it close to my home?” Sisson answers. For that matter, why not just do the filming here? Charlottesville is well known as an arts-friendly community, and although the City has no official film office to help moviemakers scout locations and such, there are also no permits or fees to deal with. Not to mention the wealth of potential local collaborators who would be an added bonus.

“There’s a lot of talent in this area,” Sisson concurs. “There’s no reason why a film can’t be shot around here.”

But first Sisson needs to find his next script, raise capital from investors and find a name for his company—Cavalier Productions is the current frontrunner. Although Charlottesville has been home to a spurt of interest in guerilla and documentary filmmaking recently, perhaps an indie picture company is poised to steal the scene.—Chris Smith