Joe Pitts

This provision will get products to the market faster because innovators will be able to get clinical trials underway in a timely and predictable way.

This lack of predictability in the timing of DEA scheduling decisions leads to unnecessary uncertainty in the drug development process and needless delays in patients' access to new therapies.

It now takes, on average, well over a billion dollars and 14 years from the time a drug is discovered to the time of approval.

H.R. 4299, the Improving Regulatory Transparency for New Medical Therapies Act, which Ranking Member Pallone and I introduced.

H.R. 4069, the Ensuring Patient Access and Effective Drug Enforcement Act, introduced by Reps. Marino and Blackburn, will facilitate greater collaboration between industry stakeholders and regulators in an effort to combat our Nation's…

Today's legislative hearing focuses on three bills designed to improve the predictability and transparency in Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) regulation.

This lack of predictability in the timing of DEA's scheduling decisions leads to unnecessary uncertainty in the drug development process.

H.R. 4299, which seeks to improve the transparency and consistency of DEA's scheduling of new FDA-approved drugs.

H.R. 4250, the Sunscreen Innovation Act, introduced by Representatives Whitfield and Dingell, seeks to expedite the FDA's approval process for active ingredients in sunscreens.

I am pleased with Dr. Murphy's bill. It includes a provision to extend the liability for doctors who volunteer in behavioral health clinics.

This has been a very important hearing, very compelling testimony, very informative.

The continued hiding behind HIPAA has got to stop.

I would like to commend my colleague from Pennsylvania, Dr. Murphy, for his yearlong investigation into mental health issues.

Congress is aware of your plight and we can do better.

For far too long, those who need help have been getting it the least, and where there is no help, there is no hope.

Millions of Americans suffer with severe mental illnesses, such as bipolar disorder, schizophrenia, and major depression.

I am very pleased to ask all Members to support S. 1557, very important legislation with bipartisan support, and I yield back the balance of my time.

Without objection, so ordered.

Would you commit to working with the Committee to provide any other communications between agency officials?

The chair thanks the gentleman and now recognizes the gentleman from Florida, Mr. Bilirakis, 5 minutes for questions.

The chair thanks the gentleman.

Would you please provide the Committee with the minutes from this February 2013 meeting?

FDA has admitted that the proposed changes will open generic manufacturers up to greater liability under state tort lawsuits.

The only outcome I see if the rule is enacted is mass confusion.

The proposed rule undermines the 'sameness' requirement in Hatch-Waxman and will result in situations where multiple FDA-approved, therapeutically equivalent products will have different safety-related labeling.