Just above progress on an Ebola vaccine, Time magazine ranks the “The Sunscreen Innovation Act” (SIA) as the seventh most remarkable health advancement for 2014. The bill was signed into law by President Obama November 26, 2014 – it reformed the FDA application process and created a new pathway to market for sunscreen advanced technology.
Here’s the Delaware connection: The origins of the SIA happened here at Ashland Inc. (Ashland is the company that acquired Hercules in 2008), and the project was led by Town Square Delaware contributor John Riley, who in his day job manages government relations for Ashland. Here Riley explains how he became involved with the project and managed to get a bill passed during a Congressional term considered one of the least productive in history.
TSD: Why does a specialty chemical company like Ashland care about sunscreens, and how did you come to lead this project?
JR: Ashland makes many active ingredients that go into various pharmaceutical and personal care products, including sunscreens. We conduct research on these products in Wilmington and Bridgewater, N.J., and manufacture a very successful product at our Columbus, Ohio, plant. This particular product, Escalol S, has been approved and in use in Europe, Asia and Latin America since the 1990s, however the U.S. application had been backlogged at the FDA since 2005 with no word on its status. In addition, there were seven other sunscreen filters in the queue, some going back to 2002. All of these products had to have demonstrated five years of safe and effective use in other jurisdictions before a company could even apply.
TSD: It seems difficult to believe that it would take an act of Congress to bring a sunscreen ingredient to market – particularly a product deemed to be safe and effective based on over a dozen years of use in countries with comparable regulatory systems. Can you explain how this happened?
JR: That will not be easy. When it was first brought to my attention in the spring of 2013. I thought I would just contact members of our Congressional delegation and ask them to make a few contacts at the FDA and all would be well. But for valid reasons Congress is reluctant to intervene with FDA in areas such as drug approval – and sunscreen ingredients are regulated as an over the counter (OTC) drug. Congress does get involved at the policy level, but not on behalf of a specific application. At that point in the process it wasn’t clear what the solution might be.
TSD: What steps did you take at that point?
JR: Recognizing that in today’s Washington it is difficult to have your voice heard, let alone change the way our government operates, we realized that Ashland would need allies and FDA experts – I had no experience working with the agency. The logical place to start was with other companies such as BASF and L’Oreal who were caught in the same bureaucratic swamp and the public health organizations that care about cancer and sun protection. For legal and technical expertise we met with the Holland & Knight firm in DC who was doing other work for us at the time. Turns out they had a strong team for FDA issues. Together the group of us requested a meeting with the agency – it took a couple months before we were in front of them.
TSD: What happened at the FDA meeting?
JR: Prior to the meeting we continued to dig into the history of the problem and frankly began to become even more discouraged. We discovered that there had been previous attempts to break the logjam politically and that the FDA did not budge. In fact it was impossible to even learn the status of the applications – other than a general statement that the applications were complete. While the businesses were frustrated due to the fact that they could not access the U.S. market, the public health organizations were deeply concerned that Americans were dying from melanoma at a rate of one every hour. It is a scientific fact that the sun’s UVA rays are responsible for many melanoma cases and it was clear that use of broad spectrum sunscreens can protect against the harmful rays of the sun.
The meeting with the FDA was even more discouraging than the history of the problem. Meeting with the head of the OTC division and more than a dozen of their lawyers and staff, we learned that the agency was basically tied in knots due to what is known as their “rule making process.” Unfortunately they gave us no indication of how the issue would ever be resolved. So we left the meeting convinced the solution would have to be a change in the process which meant a bill would be required.
TSD: How did you convince Congress to take on the issue?
JR: Mostly lots of shoe leather knocking on over 100 doors, focusing our attention on members who served on the committees of jurisdiction and working with the health advocates: organizations like the Melanoma Research Alliance, the Melanoma Research Foundation, the Skin Cancer Foundation, the American Cancer Society, the Foundation for Mohs Surgery, leading dermatologists and many more. From my standpoint it was important to have others, not just the “chemical” or cosmetic product companies out front making the case. H&K ran an excellent lobbying and PR strategy bringing the issue to the attention of important publications – in fact on the day the bill was introduced we made the front page of the Washington Post. I had many Hill staffers calling me that day to tell me about the article.
TSD: What was the role of the Delaware delegation?
JR: Very supportive – we met with them early and they were among the first to sign onto the bill as co-sponsors. However our delegation members had never been involved with sunscreen issues previously and did not serve on the key health committees, so we had to find our lead sponsors and bill champions elsewhere. Our Republican Senate sponsor was Johnny Isakson of Georgia, a melanoma survivor and the Democratic sponsor was Jack Reed of Rhode Island, perhaps the most knowledgeable Senator on the subject. In the House our lead Republican sponsor was Ed Whitfield of Kentucky. A ranking member of the important Energy & Commerce Committee (E&C), Congressman Whitfield became engaged on a personal level, visiting our Ashland Kentucky plant where we make precursor products for these ingredients. Like Isakson he became immersed in the details and often met with the media to discuss the importance of the issue. Our Democratic sponsor was John Dingell of Michigan. In Congress since Ike was president, Congressman Dingell was a former E&C committee chairman and the dean of the House on FDA issues.
TSD: So you told the story and it was smooth sailing to passage?
JR: Not exactly – trying to gain momentum was extremely challenging. Among other things the committees of jurisdiction had a back-up of issues they were dealing with. However, like many issues and challenges in this world there can be an individual or an inflection point that turns the tide. In this case it came about when a young woman from Georgia, Jackie King, decided to add her voice to the fight. Age 21 and struggling with stage 4 melanoma, Jackie visited leaders on Capitol Hill with staff from the Melanoma Research Alliance (MRA), participated in a press event and was interviewed in a three minute video that went viral. Suddenly the Sunscreen Innovation Act became an issue about real people, particularly young women. Statistics typically cited by advocates indicate that melanoma rates had increased by 800% among young women since the 1970’s. Jackie brought passion to the campaign and although her own melanoma was not caused by the sun it deeply frustrated her that many melanomas were preventable and she did not want to see others suffer in the way that she had.
TSD: Would success with the SIA be an occasion where you could say something good came from “lobbying”?
JR: Certainly with the Jack Abramoff and “earmark” scandals, the whole process of lobbying has been called into question. But I would argue that most lobbying is a good thing and the whole system would break down if not for the lobbyists. In a sea of overwhelming issues and information they educate members and staff on issues critical to the country and help to garner support from various quarters and create momentum in order to get a bill through. I am a big believer in the clause of the First Amendment that says that Congress will make no law “prohibiting the petitioning of governmental redress of grievances.”
TSD: Did you have a big celebration after the bill was signed into law?
JR: We did have a small but quiet celebration in December – I say quiet because Jackie King died just a few days before the bill unanimously passed the Senate. I hope everyone will take a minute to see the legacy Jackie left for us in this video.
TSD: When do you expect Americans to have access to Ashland’s product and the advanced sunscreens that have been available around the world as far back as the 1990s?
JR: I wish I could say. If FDA followed the law and the deadlines they agreed to, it would be possible to process the applications and have product available by this summer. But after failing to respond to our application for nine years, the FDA decided to respond as the bill was being unanimously passed by the Senate. In the feedback letter they requested additional tests that will take two to three years, thus rendering it impossible to meet any of the deadlines. It looks like there is no choice but to go back to Congress to ask them to intervene. The frustration to the companies and the health advocates is that FDA seems to focus primarily on a hypothetical risk while the known risk of skin cancer grows and grows. But I prefer to look at this as the glass being half full – many in Washington said we could never get a bill passed, so stay tuned!