Tag Archives: fda

Legislation Favorable to Drug, Medical Device Manufacturers Passes Senate, Heads to President

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Legislation which passed the Senate Thursday ensures that drug and medical devices can move to the market quicker. Manufacturers of these products would pay higher user fees and the revenue raised would help the U.S. Food and Drug Administration (FDA) review the items in a more expedited process. The law governing this process was set to expire by September 30, so it was imperative that the Senate act before members left for their August recess.

The legislation passed the Senate 94-1 with both Indiana senators supporting the legislation. The bill was not amended in the Senate and so therefore it now heads to the President for final signature.

The Indiana Chamber advocated for the passage of this bill during the Hoosiers Work for Health summit in July.

The legislation aligns with the Chamber’s legislative policy regarding the FDA: “The FDA has an important responsibility to make sure consumers get expeditious access to safe and effective products. Thus, the Indiana Chamber supports a well-resourced FDA, especially in the area of drugs and medical devices, through appropriated funds and user fees (tied to specific and measurable performance requirements for the FDA).”

Health Care: Donnelly Co-Authors Bipartisan Bill to Speed Up FDA Approvals for Devices; Young Reaches Across the Aisle on ACA

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Senators Joe Donnelly (D-IN) and Cory Gardner (R-CO) have re-introduced the bipartisan FDA Regulatory Efficiency Act, which would allow the Food and Drug Administration (FDA) to bring innovative medical devices to market more quickly.

Donnelly stated, “As scientists and innovators across Indiana and our country work to find new cures and therapies, we should be making it easier for them to bring these products safely to those who need them. I’m proud to work with Sen. Gardner on this bipartisan legislation to cut through the red tape at the FDA and safely speed up the approval process.”

The FDA Regulatory Efficiency Act would help the FDA concentrate on high-priority activities by authorizing third parties to approve quality systems of device companies. Authorized third parties could only approve changes that do not involve major technology changes or changes in the use of the product. The legislation would still hold companies accountable for their quality systems, while also helping to alleviate the overwhelmed FDA. Donnelly and Gardner first introduced the legislation in October 2015.

Health Care Reform Notes
Freshman Sen. Todd Young has reached across the aisle in an attempt to find common ground on health care. He recently sent a letter to all Democratic senators urging them to share their views on what’s working and what’s not with the Affordable Care Act. Young is a member of the Senate Health, Education, Labor and Pensions Committee, which will have a key role in shaping the Senate’s version of health care reform.

Congresswoman Jackie Walorski (IN-02) is touting the American Health Care Act (AHCA), as passed in the U.S. House of Representatives, and how it “brings us closer to a better health care system that puts patients first.” Her editorial appeared Sunday in the South Bend Tribune.

Congressman Larry Bucshon, M.D. (IN-08), who sits on the House Committee on Energy and Commerce where he is a member of the Subcommittees on Health, is using his web site to promote the Washington Post’s fact-checking of several recent claims about the AHCA. One is on coverage for those with pre-existing conditions and the other on classification of assault as a pre-existing condition; both claims were deemed untrue.

Chamber Promotes Life Sciences in D.C.

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7324001The Indiana Chamber is a proud partner in Hoosiers Work for Health, which promotes the biopharmaceutical and life sciences industry, and visited with Indiana’s elected representatives in Washington, D.C. July 15-16 to discuss issues such as patent
reform, taxation and FDA regulatory procedures.

The Chamber joined several other Hoosiers Work for Health representatives for office visits on Capitol Hill. The group met with Reps. Susan Brooks (R-5th District) and Larry Bucshon (R-8th District), both members of the House Energy and Commerce Committee, as well as Rep. Todd Young (R-9th District), who serves on the House Ways and Means Committee. The group also visited with key staff members for Sens. Dan Coats (R) and Joe Donnelly (D) while the Senate held floor votes on an education bill.

It is clear from the conversation with Indiana’s elected officials that they understand the importance of the biopharmaceutical/life sciences sector to the economic health of Indiana. This sector directly supports more than 20,000 jobs across the state and generates $19 billion in economic output. By creating high paying jobs, biopharmaceutical companies build a strong foundation from which we can grow our state economy – providing stability and prosperity into the future.

Once Again, Be Honest With Your Customers

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Here’s the scenario: a company realizes that something has gone wrong with a product and then decides to quietly pull the product from store shelves. No announcement. No formal recall. Nothing, until an online brigade of justifiably angry customers makes a stink and demands answers. Oh yeah, and a Food and Drug Administration inquiry. Finally, a voluntary recall is issued.

Quite a story, and unfortunately it’s a true one. How many times do we have to go through this simple lesson? Be honest with your customers.

The most recent company in question is Chobani, which produces “Greek”-style yogurt in a variety of flavors for adults and children. Chobani boasts a motto of “Go real,” and says it doesn’t use artificial preservatives in its line of yogurt.

Customers started complaining almost a week before the official recall that yogurt tasted “fizzy” and cup lids were bulging or bloated. The company traced this phenomenon to its Idaho plant and a type of mold that is “common in the dairy environment, particularly when using only natural ingredients that are absent of artificial preservatives,” says the company founder, Hamdi Ulukaya, in an apology letter on the company web site and Facebook page.

This is where it gets personal for me. I buy Chobani for my family, one of the reasons being that the company doesn't use artificial preservatives. So, I can be pretty understanding that this issue is more common in products that don’t use artificial preservatives.

But the thing that burns me is the perceived  sneakiness of it (or actual sneakiness – time and the FDA will tell us that one). The company could have voluntarily recalled the affected product as soon as it knew something was wrong.

In fact, I would have been saved from purchasing any of the bad yogurt had they done that last week. Two boxes of my daughter’s favorite yogurt tubes and several cups of yogurt went in the trash; unfortunately, I had already given her several of the tubes before I found out about the issues. In our case, an upset stomach over Labor Day weekend that I couldn't attribute to anything else was the worst that seems to have come of it, thankfully.

The Chicago Tribune reports that the FDA is trying to conclude if the company was communicating with the public the way it should have been. Since we still don’t know what specific kind of mold it was or why they went about it the way they did, I am not foreseeing a good conclusion from that investigation.

But I could be wrong. Oh, wait, what’s that old adage? The customer is always right.

After this devious deal, I don’t see myself being a customer of Chobani any longer.

Execs Say Washington is Going Too Far

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A couple of interesting observations from Ivan Seidenberg, CEO of Verizon Communications and chairman of the Business Roundtable. This group of top executives has been strongly courted by the Obama administration and included in various policy discussions.

Seidenberg, speaking at the Economic Club of Washington earlier this week, however, had the following quotes:

  • He accused the president and Democratic lawmakers of creating an "increasingly hostile environment for investment and job creation."
  • He added that Democrats in Washington are pursuing tax increases, policy changes and regulatory actions that together threaten to dampen economic growth and "harm our ability . . . to grow private-sector jobs in the U.S."
  • "In our judgment, we have reached a point where the negative effects of these policies are simply too significant to ignore. By reaching into virtually every sector of economic life, government is injecting uncertainty into the marketplace and making it harder to raise capital and create new businesses."

And it’s not just Seidenberg. The Washington Post reported that: Seidenberg first expressed his concerns about the direction of Democratic economic policy in a meeting last month with White House budget director Peter Orszag. When Orszag asked for specifics, Seidenberg polled the members of the Business Roundtable and a sister organization, the Business Council. The result was a 54-page document, delivered to Orszag on Monday, chock full of bullet points about actions taken or considered by a wide array of executive agencies, including the White House Middle Class Task Force and the Food and Drug Administration.

"We believe the cumulative effect of these proposals will help defeat the objectives we all share — reducing unemployment, improving the competitiveness of U.S. companies and creating an environment that fosters long-term economic growth," Seidenberg wrote in a cover letter for the document, titled "Policy Burdens Inhibiting Economic Growth."